[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"merkel-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:merkel-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,43,68,98,125,152,179,208,240,287,310,349,371,418,439,459,482,501,535,567,644,672,700,722,744],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100629257","phase-1-astx727--retifanlimab-dlwr-for-advanced-merkel-cell-after-progression-on-anti-pd-l1-100629257",false,"NCT07472322","ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1","UW26001 Phase I\u002FII Study on the Safety, Tolerability, and Preliminary Efficacy of ASTX727 (Decitabine\u002FCedazuridine) and Retifanlimab-dlwr in Patients With Advanced Merkel Cell Carcinoma Who Have Progressed on Anti-PD-(L)1 Inhibitor","Inclusion Criteria:\n\n* Individuals age ≥ 18 years at the time of consent\n* ECOG Performance Status of 0-2\n* Histological or cytological evidence\u002Fconfirmation of Merkel cell carcinoma (MCC)\n* Must have unresectable stage III\u002FIV MCC per American Joint Committee on Cancer (AJCC) 8th edition. Participants must be considered unresectable based on the judgment of the treating physician\n* Participants must have progressed on prior programmed cell death protein-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor-based therapy. Participants must have received at least 2 doses of anti-PD-1 or anti-PD-L1 inhibitor. Relapsed\u002Frefractory disease from prior adjuvant PD-1 or PD-L1 inhibitor is permitted. Prior treatment with retifanlimab is permitted.\n* Demonstrate adequate organ and marrow function; all screening labs to be obtained within 28 days prior to registration\n\nExclusion Criteria:\n\n* Prior treatment with a hypomethylating agent (HMA) (e.g., azacitidine, decitabine, guadecitabine)\n* History of clinically significant intolerance, hypersensitivity, or treatment discontinuation of an anti-PD-1 or anti-PD-L1 inhibitor due to grade 3 or greater immune-related adverse events (irAEs). Participants who are able to be successfully rechallenged with anti-PD-(L)1 inhibitor without recurrence of grade 3 or greater irAEs are permitted on study. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study drug(s) may be included (e.g. hearing loss, hypothyroidism, adrenal insufficiency, type 1 diabetes, or other endocrinopathies) after consultation with the sponsor investigator\n* Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \\> 30 Gy within 6 months before the first dose of study treatment\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration\n* Active infection requiring systemic therapy within 7 days prior to registration","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are:\n\n* Can the combination shrink cancer and lower the chance of the cancer growing or spreading?\n* Is the combination better than standard of care for Merkel cell cancer?\n\nParticipants will:\n\n* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years.\n* Visit the clinic once every 2 weeks for checkups and tests",[27,28,29],"Merkel Cell Carcinoma","Merkel Cell Carcinoma, Stage III","Merkel Cell Carcinoma, Stage IV","NOT_YET_RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":20},"2026-07",{"date":38,"type":20},"2031-05",{"name":40,"class":41},"University of Wisconsin, Madison","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100437352","phase-1-neoadjuvant-cemiplimab-in-newly-diagnosed-or-recurrent-stage-i-ii-merkel-cell-carcinoma-and-locoregionally-advanced-cutaneous-squamous-cell-carcinoma-100437352","NCT04975152","Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma","Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: Safety and Biomarker Analysis","Inclusion Criteria:\n\n* Histologically proven diagnosis of Merkel cell carcinoma (MCC).\n* Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with local or regional disease recurrence.\n* Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is determined to not be clinically indicated then it would not be required to be completed and only the tumor excision would be required.\n* Patients with stage III to stage IV (M0) CSCC of the head\u002Fneck, extremity, or trunk, and selected patients with stage II CSCC (≥3 cm longest diameter lesion in an aesthetically-sensitive region), for whom surgery is planned.\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged at least 18 years\n* ECOG performance Status of 0, 1, or 2\n* Adequate baseline laboratory assessments within 28 days of study registration:\n\n  1. Adequate hepatic function: i. Total bilirubin ≤1.5 x upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤3 x ULN) ii. Transaminases (aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\]) ≤3 x ULN iii. Alkaline phosphatase (ALP) ≤2.5 x ULN\n  2. Adequate renal function: Serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) \\>30 mL\u002Fmin according to the method of Cockcroft and Gault.\n  3. Adequate bone marrow function: i. Hemoglobin ≥9.0 g\u002FdL ii. Absolute neutrophil count (ANC) ≥1.0 x 109\u002FL iii. Platelet count ≥75 x 109\u002FL\n* Patients who are HIV+ with undetectable HIV viral load are eligible.\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of cemiplimab administration.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n\nExclusion Criteria:\n\n* Concurrent malignancy other than localized CSCC and\u002For history of malignancy other than Merkel cell carcinoma within 3 years of date of registration on the study, except for tumors with negligible risk of metastasis or death, such as adequately treated (BCC) of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low- risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score ≤6 and prostate-specific antigen (PSA) ≤10 ng\u002FmL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of \\>12 months for which the management plan is active surveillance.\n* Patients with hematologic malignancies (eg, chronic lymphocytic leukemia \\[CLL\\]).\n* Ongoing or recent (within 5 years of registration date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). Further, patients requiring chronic immune-suppressive therapy are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.\n* Pregnancy or lactation.\n* Has participated in a study of an investigational agent or an investigational device within weeks of the enrollment date.\n* Receipt of a live vaccine within 28 days of the registration date.\n* Has had prior systemic anti-cancer immunotherapy for MCC. Examples of immune modulating agents include but are not limited to blockers of CTLA-4, 4-1BB (CD137), or OX-40, therapeutic vaccines, anti-PD-1\u002FPD-L1.\n* Immunosuppressive corticosteroid doses (\\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab\u002Fplacebo.\n\nNOTE: Patients who require brief course of corticosteroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded. People taking steroids for physiologic replacement (ie, adrenal insufficiency) are NOT excluded.\n\n\\- Has received treatment with an approved anticancer systemic therapy within 4 weeks of the registration date or has not yet recovered (ie, ≤ grade 1 or baseline) from any acute toxicities except for laboratory changes as described in the inclusion criteria.\n\nNOTE: Patients receiving bisphosphonates or denosumab are not excluded.\n\n* Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n* Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.\n* Encephalitis, meningitis, or uncontrolled seizures in the year prior to screening.\n* Patients with myocardial infarction within 6 months prior to the registration date.\n* Any infection requiring hospitalization and\u002For intravenous antibiotic therapy within 2 weeks of the registration date.\n* Active tuberculosis.\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.\n\nNOTES:\n\n* Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n* Patients with HBV (hepatitis B surface antigen positive; HepBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection AND receiving anti- viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n\nPatients who are HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n\n* History of immune related pneumonitis within the last 5 years.\n* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to the registration date.\n* History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.\n* Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.\n* Patients with a history of solid organ transplant (exception: patients with prior corneal transplant are not excluded).\n* Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation in a clinical trial due to high safety risks and\u002For potential to affect interpretation of results of the study.\n* Known psychiatric or substance abuse disorders that would interfere with participation with the requirements of the study.",{"count":51,"type":20},36,[23],"The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).",[27,55],"Cutaneous Squamous Cell Carcinoma",[57],"Skin Cancer","RECRUITING","2026-06-24",{"date":61,"type":34},"2026-06-25",{"date":63,"type":34},"2021-10-22",{"date":65,"type":20},"2028-03",{"name":67,"class":41},"H. Lee Moffitt Cancer Center and Research Institute",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":72,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":76,"type":20},60,[23,24],[79,80,81,82,27,83,84,85,86],"Melanoma","Non-small Cell Lung Cancer","Squamous Cell Carcinoma (Skin)","Renal Cell Carcinoma","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-06-10",{"date":89,"type":34},"2026-06-11",{"date":91,"type":34},"2025-07-29",{"date":93,"type":20},"2029-10-02",{"name":95,"class":96},"AstraZeneca","INDUSTRY",13,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":42},"100245918","phase-2-cytotoxic-t-lymphocytes-in-treating-patients-with-malignancies-with-bk-andor-jc-virus-100245918","NCT02479698","Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and\u002For JC Virus","Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection","Inclusion Criteria:\n\n* Patients ≥ 2 years. English and non-English speaking patients are eligible.\n* Immunocompromised patients; and\u002For Non-immunocompromised patients with PML\u002FJC virus Encephalitis; and\u002For patients with any type of malignancies; and\u002For HIV\u002FAIDs; and\u002For history of solid organ transplant; and\u002For Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per RECIST criteria.\n* Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood PCR positive for BK virus and\u002For JC viral encephalitis and\u002For JC end-organ disease and\u002For polyomavirus.\n* Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg\u002Fkg\u002Fday of prednisone.\n* Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.\n* Written informed consent and\u002For signed assent from patient, parent or guardian. Patients with cognitive impairments are eligible.\n* Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.\n* Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.\n* Patients may be re-enrolled in the protocol should the infection re-occur, provided they meet all the other eligibility criteria at the moment of re-enrollment.\n\nExclusion Criteria:\n\n* Patients receiving prednisone \\> 0.5 mg\u002Fkg\u002Fday at time of enrollment, or have received ATG within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.\n* Patients with other uncontrolled infections (except HIV\u002FAIDS). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patients with active acute (GVHD) grades II-IV",{"count":106,"type":20},100,[24],"This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and\u002For JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and\u002For JC virus.",[110,111,112,113,114,27,115,116],"Acquired Immunodeficiency Syndrome","BK Virus Infection","Human Immunodeficiency Virus","JC Virus Infection","Malignant Neoplasm","Merkel Cell Polyomavirus Infection","Viral Encephalitis",{"date":118,"type":34},"2026-06-12",{"date":120,"type":34},"2015-07-23",{"date":122,"type":20},"2027-07-31",{"name":124,"class":41},"M.D. Anderson Cancer Center",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100445155","phase-1-mem-288-oncolytic-virus-alone-and-in-combination-with-standard-of-care-therapy-in-advanced-solid-tumors-100445155","NCT05076760","MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and provide informed consent.\n2. Willingness and ability to comply with scheduled study visits and procedures.\n3. Adult men or women age ≥ 18 years.\n4. ECOG performance status of 0 or 1.\n5. Part 1A monotherapy: Advanced\u002Fmetastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.\n6. Parts 1B and 1C combination: Advanced\u002Fmetastatic NSCLC which has progressed following front-line anti-PD-1\u002FPD-L1 with or without concurrent chemotherapy.\n7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.\n\n   1. Non-small cell lung cancer (NSCLC)\n\n      Part 1A monotherapy\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).\n      * Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.\n\n      Part 1B MEM-288 plus nivolumab combination\n      * Must have first progression more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy\n\n      Part 1C MEM-288 plus docetaxel combination must have either:\n      * first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or\n      * progressed following initial first line anti-PD-1 or PD-L1 monotherapy followed by 2nd line platinum chemotherapy (with or without continuation of their first line anti-PD-1 or PD-L1 therapy).\n   2. Cutaneous squamous-cell carcinoma (cSCC)\n\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and\u002For checkpoint inhibitor therapy.\n   3. Merkel cell Carcinoma\n\n      * Must have progressed on standard checkpoint inhibitor therapy.\n   4. Melanoma\n\n      * Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.\n      * Subjects must have received an anti-PD-1\u002F PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.\n   5. Pancreatic cancer\n\n      * Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).\n   6. Triple negative breast cancer (TNBC)\n\n      * Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and\u002For anthracycline-based therapy.\n   7. Head and Neck Cancer\n\n      * Prior treatment requirement in the metastatic or unresectable locally advanced setting include:\n      * Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings\n      * Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.\n\n   a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.\n10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be \\> 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.\n\n    a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.\n11. Measurable disease, as defined per RECIST version 1.1.\n12. Prior history of brain metastases are eligible, provided:\n\n    1. Brain metastases have been treated\n    2. Asymptomatic from the brain metastases\n    3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study\n    4. Brain metastases are stable on pre-registration imaging\n    5. No evidence of leptomeningeal disease\n13. Life expectancy \\> 3 months.\n14. Adequate organ and marrow function as defined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002FL\n    2. Hemoglobin ≥90 g\u002FL (or ≥9 g\u002FdL)\n    3. Platelets ≥100 x 10\\^9\u002FL\n    4. Calculated creatinine clearance of \\>50 mL\u002Fmin using Cockcroft Gault equation\n    5. Total bilirubin ≤ 1.5 x institutional upper limit of normal\n    6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal\n    7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal\n15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:\n\n    1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n    3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding.\n2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.\n4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.\n5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.\n6. Concurrent use of other anticancer approved or investigational agents.\n7. Clinically significant, uncontrolled heart disease and\u002For recent cardiac event (within 6 months), such as:\n\n   1. unstable angina within 6 months prior to screening\n   2. myocardial infarction within 6 months prior to screening\n   3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   4. cardiac arrhythmias not controlled with medication\n8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).\n9. Any form of active primary or secondary immunodeficiency.\n10. Receiving ≥10 mg daily prednisone (or equivalent).\n11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical\u002Fdysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.\n12. Active systemic infections requiring intravenous antibiotics.\n13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network \\[NCCN\\] recommended systemic therapies).\n14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.\n15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).\n16. Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy.",{"count":133,"type":20},40,[23],"This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.\n\nThe dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD.\n\nThe dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection.\n\nIn a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses.\n\nThe study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.",[137,138,139,140,55,27,79,141,83,142],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Pancreatic Cancer","Head and Neck Cancer","2026-06-09",{"date":89,"type":34},{"date":146,"type":34},"2022-04-21",{"date":148,"type":20},"2031-12",{"name":150,"class":96},"Memgen, Inc.",2,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100517752","phase-1-a-study-of-crd3874-si-in-people-with-solid-tumors-100517752","NCT06021626","A Study of CRD3874-SI in People With Solid Tumors","A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced\u002FMetastatic Malignant Solid Tumors","Inclusion Criteria:\n\n* Male or female age ≥ 18 years at the time of informed consent.\n* Be capable, willing, and able to provide written informed consent.\n* Be willing to comply with clinical trial instructions and requirements, including tumor biopsies (if feasible and required per protocol).\n* Patients must have a locally advanced or metastatic cancer, a malignant solid tumor that has progressed on at least one line of systemic therapy or for which no standard treatment is available, the participant is intolerant to available treatment, or the participant declined standard of care systemic therapy.\n* In the dose escalation phase study patients with the following tumor types will be eligible: Of note patients who declined or were intolerable of standard of care systemic therapy will be considered in all dose expansion cohorts.\n* Head and neck squamous cell carcinoma (HNSCC)\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic HNSCC and must have received 1-2 prior lines of systemic anti-cancer therapy including a checkpoint inhibitor (patients treated initially with immune checkpoint blockade alone followed by the addition of other drugs in combination \\[i.e., cytotoxic chemotherapy or EGFR inhibitor\\], will be considered 1 line of therapy.\n* HPV positive (p16 IHC positive or HPV RNA ISH positive), PD-L1 CPS score high (≥1)\n* HPV negative (p16 IHC negative or HPV RNA ISH negative), PD-L1 CPS score high (≥1)\n* Adenoid cystic carcinoma (ACC)\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic ACC (cancers arising from non-salivery gland primary sites are eligible) and may have received none or up 2 prior lines of systemic anti-cancer therapy.\n* Merkel cell carcinoma (MCC)\n* Participants must have histologically or cytologically confirmed recurrent and or metastatic MCC and must have received at least one but no more than 3 prior lines of systemic anti-cancer therapy including a checkpoint inhibitor and may not have received prior chemotherapy for MCC.\n* Monotherapy alone\n* Radiation therapy\n* Patients will receive palliative radiation therapy to a tumor site if they have at least one other site of measureable disease that can be chosen as the target lesion to assess response to investigational therapy.\n* Sarcoma that has demonstrated clinical benefit or an objective response to immune checkpoint blockade or sarcoma subtypes that are considered immunogenic subtypes including but not limited to undifferentiated pleomorphic (UPS) or myxofibrosarcoma (MFS), angiosarcoma, alveolara soft part sarcoma, or undifferentiated sarcoma will be considered.\n* Melanoma\n* Uveal Melanoma\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic uveal melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including tebentafusp (if HLA-A 02:01+, unless patient declined or was deemed ineligible) and\u002For immune checkpoint inhibitor. Melphalan PHP will count as a line of therapy if give on its own. Unlimited partial hepatic directed therapy will be permitted.\n* Mucosal and Acral melanoma\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic mucosal or acral melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including prior exposure to immune checkpoint inhibition. Patients treated with BRAF-MEK therapy may have up to 3 prior lines of therapy.\n* Non small cell lung cancer\n* Participants must have histologically or cytologically confirmed locally advanced\u002Fmetastatic non-small cell lung cancer with prior exposure to immune checkpoint inhibition and received at least one but no more than 2 prior lines of systemic anti-cancer therapy.\n* Participants must have histologically or cytologically confirmed locally advanced\u002Fmetastatic sarcoma and must have received at least one but no more than 2 prior lines of systemic anti-cancer therapy. Patients will receive palliative radiation therapy to a tumor site if they have at least one other site of measureable disease that can be chosen as the target lesion to assess response to investigational therapy\n* Adequate performance status: ECOG 0 or 1\u002FKPS 100-70%.\n* Life expectancy of at least three months after the first CRD3874 infusion, according to the Investigator's opinion\n* Presence of measurable disease per RECIST v1.1.Target lesion(s) must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* In the dose expansion phase , participants must agree to have a pretreatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom the associated procedure would result in unacceptable risk, in the opinion of the Investigator, or patients who do not wish to have a biopsy, archival tissue (most recently procured sample where tissue is available) may be used instead, if available.\n* In the dose expansion phase , participants must agree to on-treatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the opinion of the Investigator, or patients who do not wish to have a biopsy- may be exempted from the biopsy requirement with discussion with the Principal Investigator .\n* Female subject of childbearing potential (defined as a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive months) should have a negative serum pregnancy testing at screening visit and within 72 hours prior to the first dose of study medication.\n* Adequate organ function determined within 14 days of treatment initiation, defined as follows:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,000\u002Fmm\\^3 (1.0 x 10\\^9\u002FL)\n  * Platelet count ≥ 100,000\u002Fmm3 (100 x 10\\^9 \u002FL)\n  * Serum bilirubin ≤ 1.2x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin level \\> 1.2x ULN\n  * Aspartate aminotransferase (AST) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases\n  * Alanine aminotransferase (ALT) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases\n  * Albumin ≥ 2.5mg\u002FdL.\n  * Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by Cockcroft-Gault formula or CKD-EPI 2021\n  * International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n  * Activated partial thromboplastin time (aPTT) ≤ 1.5x ULN unless participant is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants\n  * Left ventricular ejection fraction (LVEF) \\> 50%, as measured by echocardiogram (2D-ECHO) or multi-gated acquisition scan (MUGA)\n\nExclusion Criteria:\n\n* Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG), (NCI CTCAE v5.0 Grade ≥ 3)\n* Evidence of clinically significant immunosuppression such as the following:\n\n  * Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease\n  * Concurrent opportunistic infection\n  * Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 7 days prior to enrollment. In the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid (equivalent to \\\u003C\u002F=10mg\u002Fday prednisone) use may be permitted at the discretion of the principal investigator.\n  * Current use of immunosuppressive medication, EXCEPT for the following:\n\nI. Intranasal, inhaled, ocular, topical steroids, or local steroid injection (e.g., intraarticular injection) II. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent III. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n\n* Prior organ transplantation, including allogenic stem-cell transplantation. Consideration will be given to allow patients with a history of autologous transplantation enroll if they are at least 5 years beyond the completion of the transplant pending discussion with the principal investigator.\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.\n* Systemic antibiotics received ≥ 7 days prior to the first dose of study drugs.\n* Uncontrolled medical condition including current active infection requiring systemic therapy or symptomatic congestive heart failure within 6 months that in the investigators opinion compromise the ability of the patient to complete all study related requirements safely\n* Inability to comply with protocol required procedures\n* Resting QTc interval by Friderica's formula ≥ 470 ms on a 12-lead electrocardiogram (ECG) for males and females\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment or 5 half-lives, if shorter.\n* Has had prior chemotherapy or targeted small molecule therapy within 3 weeks, anti-cancer monoclonal antibody (mAb) within 4 weeks or OR 5 half-lives, if shorter, or radiation therapy within 2 weeks prior to the first CRD3874 infusion prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Alopecia or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable\n  * Note: If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study therapy\n* Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment.\n* History of unstable or deteriorating cardiovascular disease within the previous 6 months prior to screening including but not limited to the following:\n\n  * Unstable angina or myocardial infarction\n  * CVA\u002Fstroke\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV\n  * Uncontrolled clinically significant arrhythmias.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Patients with previously treated brain metastases or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n* Has received a live vaccine within 30 days of the planned start of study drug. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Patients known to be positive for active Hepatitis B (HBsAg reactive with detectable HBV DNA), or Hepatitis C (HCV RNA (qualitative) is detected)\n\n  1. Patients with chronic hepatitis B (positive HBsAg and\u002For HBcAb and negative HBV DNA by PCR) are eligible for this study if they are on suppressive anti-viral therapy and deemed safe by a gastroenterologist\n  2. Patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution will be considered eligible.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) disease that is not controlled. Note HIV-positive patients will be considered eligible if:\n\n  * Established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment\n  * CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL\n  * No opportunistic infection within the past 12 months\n  * Has a known history of active TB (Bacillus Tuberculosis)\n* Women who are pregnant or breastfeeding\n* Patients expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through three months after the last dose of study treatment(s).\n* Female participants of childbearing potential and male participants who are unwilling to use acceptable method(s) of effective contraception during study treatment and until six months for female and three months for males after the last dose of CRD3874-SI. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.\n\n(Note: Women not of childbearing potential are defined as: Any female who is postmenopausal \\[age \\> 55 years with cessation of menses for 12 or more months or less than 55 years but with no spontaneous menses for at least two years or less than 55 years and spontaneous menses within the past one year but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy) and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \\> 40 IU\u002FL) or postmenopausal estradiol levels (\\\u003C 5 ng\u002FdL) or according to the definition of \"postmenopausal range\" for the laboratory involved\\] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.)\n\n* The presence of a concurrent active malignancy that in the opinion of the investigator could compromise the conduct of the study or interfere with determining the outcomes of the study objectives.\n* History of non-infectious colitis.",{"count":160,"type":20},81,[23],"This study will test the safety of a study drug called CRD3874-SI. The researchers will test different doses of CRD3874-SI to find the highest dose that causes few or mild side effects in participants. After the researchers find the highest safe dose of CRD3874-SI, they will test that dose in new groups of participants to help them learn more about the side effects of the study drug and find out whether CRD3874-SI is an effective treatment for for patients with advanced or metastatic malignant solid tumors including sarcoma and Merkel Cell Carcinoma. (MCC), Head and neck squamous cell carcinoma (HNSCC), Adenoid cycstic carcinoma (ACC), Uveal Melanoma, Muscosal and Acral melanoma, and Non small cell lung cancer. The researchers will also look at how the body absorbs, distributes, and gets rid of CRD3874-SI, and the how the body and immune system respond to CRD3874-SI.",[164,27],"Sarcoma",[166,167,168],"CRD3874-SI","23-169","Advanced\u002FMetastatic Malignant Solid Tumors","2026-06-04",{"date":171,"type":34},"2026-06-05",{"date":173,"type":34},"2023-08-25",{"date":175,"type":20},"2029-08",{"name":177,"class":41},"Memorial Sloan Kettering Cancer Center",7,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100301962","french-national-database-of-rare-dermatological-cancers-100301962","NCT03210935","French National Database of Rare Dermatological Cancers","French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas","CARADERM","Inclusion Criteria:\n\n* Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma\n\nExclusion Criteria:\n\n* Subjects without Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma\n* Patients refusal",{"count":188,"type":20},9000,"OBSERVATIONAL","Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes.\n\nCARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :\n\n* to provide epidemiological, clinical and socio-economic characteristics of patients\n* to identify new clinical or epidemiological prognostic factors for these rare cancers\n* to evaluate the impact of various treatments on outcomes",[192,27,193],"Adnexal Tumor of Skin","Advanced Basal Cell Carcinoma Requiring Systemic Treatment",[195,196,197],"Adnexal cutaneous carcinoma","Merkel cell carcinoma","Advanced basal cell carcinoma requiring systemic treatment","2026-05-20",{"date":200,"type":34},"2026-05-22",{"date":202,"type":34},"2015-11-24",{"date":204,"type":20},"2026-12-31",{"name":206,"class":41},"University Hospital, Lille",34,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":230,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":151},"100578684","phase-1-radiation-combined-with-bispecific-t-cell-engager-in-dll3-expressing-tumors-100578684","NCT06814496","Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors","RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I\u002FII Study of AMG757 \u002F Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3","RABBIT","Inclusion Criteria:\n\n1. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n2. Subjects ≥ 18 years of age at the time of signing the informed consent.\n3. Histologically or cytologically confirmed relapsed\u002Frefractory:\n\n   1. SCLC\n   2. Other tumors of small cell histology\n   3. High grade \u002F poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer, esthesioneuroblastoma, bladder cancer, testicular cancer, glioblastoma multiforme, cervical cancer; large cell neuroendocrine tumor of lung, non-small cell lung cancers with mixed neuroendocrine features, and Merkel cell carcinoma OR\n   4. DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevelant tumor type, they will be allowed to enroll on the study.\n4. Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.\n5. Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \\[FFPE\\] sample). If no archived tumor tissue is available, we request to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable or unwilling to undergo a pretreatment tumor biopsy due to extenuating circumstances (i.e., cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement with sponsor.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Minimum life expectancy of 12 weeks.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n9. Measurable lesions as defined per RECIST 1.1 within 28 days prior to the first dose of tarlatamab.\n10. Eligible for external beam radiation therapy to a previously unirradiated, measurable lesion as per standard of care.\n\n    1. For the concurrent \u002F sequential cohort of extracranial RT sites:\n\n    i. A minimum of 10 subjects with thoracic lesions (lung, mediastinum, thoracic spine, rib, or other thoracic sites) will be treated ii. Subjects with treated brain metastases are eligible (untreated brain metastases are ineligible) provided they meet the following criteria:\n\n\u003C!-- -->\n\n1. Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.\n2. There is no evidence of radiographic central nervous system (CNS) progression following therapy and by the time of study screening.\n3. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means.\n4. Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n\n   b. For the concurrent\u002Fsequential cohort of cranial RT sites: i. Previously untreated brain lesions \u002F metastases are eligible ii. Subjects with previously irradiated brain lesions are eligible provided they meet one of the following criteria:\n\n\u003C!-- -->\n\n1. Prior PCI or whole brain radiation therapy per standard of care with new and\u002For recurrent brain metastases to be treated with SRS or hfSRT\n2. Prior course(s) of SRS or hfSRT or other localized therapy with new lesion(s) to be treated with whole brain radiation therapy iii. Whole brain re-irradiation will be ineligible iv. Re-irradiation with SRS or hfSRT of previously irradiated lesion with SRS or hfSRT will be ineligible v. Craniospinal irradiation will not be allowed c. For the tarlatamab monotherapy cohort: i. Patient must have at least one measurable lesion, however that lesion does not need to be amenable to RT\n\n1\\. Patients with previously irradiated lesions that have recurred or progressed are eligible 11. Adequate organ function, defined as follows:\n\na. Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109\u002FL ii. Platelet count ≥ 100 x 109\u002FL iii. Hemoglobin \\> 9 g\u002FdL (90 g\u002FL) b. Coagulation function: i. Prothrombin time (PT)\u002Finternational normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.\n\nc. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. hepatic function: i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement) ii. Total bilirubin \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for subjects with liver metastases) e. Pulmonary function: i. No clinically significant pleural effusion ii. Baseline oxygen saturation \\> 90% on room air f. cardiac function (if obtained as part of standard of care): i. Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings\n\nExclusion Criteria:\n\nRe-irradiation, unless it is SRS\u002FhfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS\u002FhfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not amenable to RT (including previously irradiated) will be only allowable on the tarlatamab monotherapy cohort.\n\nDisease Related\n\n1. Subjects are excluded from the study if any of the following criteria apply:\n\n   1. No lesion(s)\u002Fsite(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open)\n   2. Planned re-irradiation of a previously irradiated site\n   3. Leptomeningeal disease requiring craniospinal irradiation\n2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n3. Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n4. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \\> 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.\n\nOther Medical Conditions\n\n1. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of tarlatamab.\n2. History of arterial thrombosis (i.e., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.\n3. Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.\n\n   NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for \\> 48 hours.\n4. History of hypophysitis or pituitary dysfunction.\n5. Exclusion of hepatitis infection based on the following results and\u002For criteria:\n\n   a. Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).\n\n   b. Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.\n\n   c. Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.\n6. Major surgery requiring hospitalization for more than 3 days within 28 days of first dose of tarlatamab.\n7. Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n8. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n9. Human immunodeficiency virus (HIV) infection.\n\n   1. Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines.\n\nPrior\u002FConcomitant Therapy\n\n1. Subject received prior therapy with tarlatamab.\n2. Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.\n\n   Exceptions:\n\n   a. Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.\n3. Has a diagnosis of immunodeficiency (i.e., positive\u002Fnon-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.\n4. The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:\n\n   1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.\n   2. Live viral non-replicating vaccine (i.e., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care (SOC) and institutional guidelines.\n   3. End of study treatment: Live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab.\n\nOther Exclusions\n\n1\\. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab. Contraception methods for female subjects include:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable)\n3. Intrauterine device\n4. Intrauterine hormonal-releasing system\n5. Bilateral tubal ligation\u002Focclusion\n6. Vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success)\n7. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject) 2. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.\n\n   3\\. Female subjects planning to become pregnant while on study through 60 days after the last dose of tarlatamab.\n\n   4\\. Female subjects of childbearing potential with a positive pregnancy test assessed at screening and\u002For day 1 by a highly sensitive urine or serum pregnancy test.\n\n   5\\. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception (use a condom) during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   6\\. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   7\\. Male subjects unwilling to abstain from donating sperm during treatment and for an 60 days after the last dose of tarlatamab.\n\n   8\\. Subject has known sensitivity to any of the products or components to be administered during dosing.\n\n   9\\. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n\n   10\\. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.","99 Years",{"count":218,"type":20},30,[23,24],"Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites.\n\nI) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting.\n\nIII) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT.\n\nA nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.",[79,222,223,224,225,226,227,228,229,140,27],"Medullary Thyroid Cancer","Sinonasal Undifferentiated Carcinoma","Esthesioneuroblastoma","Bladder Cancer","Testicular Cancer","Glioblastoma Multiforme","Cervical Cancer","Large Cell Neuroendocrine Carcinoma of the Lung",[231],"DLL3 Expressing tumors","2026-05-19",{"date":198,"type":34},{"date":235,"type":34},"2025-09-08",{"date":237,"type":20},"2030-05",{"name":239,"class":41},"University of Arizona",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":42},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":248,"type":20},27,[24],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,79,27,270,271,272,273,274,275,82,276,277],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":280,"type":34},"2026-05-18",{"date":282,"type":34},"2025-12-18",{"date":284,"type":20},"2026-12-18",{"name":286,"class":41},"Mayo Clinic",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100484105","phase-2-phase-ii-study-of-peptide-receptor-radionuclide-therapy-in-combination-with-immunotherapy-for-patients-with-merkel-cell-cancer-100484105","NCT05583708","Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer","A Single Arm Study With Safety Run-in of Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Immunotherapy for Patients With Merkel Cell Cancer (HCRN MCC20-443; iPRRT Study)","iPRRT","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Male and female, age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-1 within 28 days prior to registration.\n4. Histological or cytological evidence of Merkel cell cancer per AJCC, 8th edition.\n5. Presence of somatostatin receptors by Ga-68 dotatate (or equivalent) imaging, which is a requirement for PRRT (lutetium Lu 177 dotatate \\[Lutathera®\\]). Must have at least one measurable lesion per RECIST 1.1.\n6. Must have progressed on treatment with an anti-PD-1\u002FL1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:\n\n   * Has received at least 2 doses of an approved anti-PD-1\u002FL1 mAb\n   * Has demonstrated disease progression after anti-PD-1\u002FL1 as defined by RECIST v1.1.\n   * Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb. Note: This determination is made by the local investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n7. Prior cancer treatment must be completed and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.\n8. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration.\n\n   * Hematological:\n\n     * Absolute Neutrophil Count (ANC): ≥ 1500\u002FuL\n     * Platelets: ≥100,000\u002FuL\n     * Hemoglobin (Hgb): ≥9.0g\u002FdL or ≥5.6mmol\u002FL\n   * Renal:\n\n     * Creatinine: 1.5 x ULN OR\n     * Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥30mL\u002Fmin for participant with creatinine levels \\>1.5 x institutional ULN\n   * Hepatic:\n\n     ---Total bilirubin: ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n   * AST(SGOT) and ALT(SGPT): ≤2.5 x ULN (≤5 x ULN for participants with liver metastases)\n   * Coagulation:\n\n     * International normalized ratio (INR) OR prothrombin time (PT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n     * Activated partial thromboplastin time (aPTT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n9. Females of childbearing potential who are sexually active with a male able to father a child must have a negative serum pregnancy test within 7 days prior to registration.\n10. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from the time of informed consent, during the study and for 7 months after the last dose of study drug(s). Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment, during the study and for 120 days after the last dose of study drug(s).\n11. Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration.\n\n    Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n    Hepatitis B screening tests are not required unless:\n    * Known history of HBV infection\n    * As mandated by local health authority\n12. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n    Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\n    Hepatitis C screening tests are not required unless:\n    * Known history of HCV infection\n    * As mandated by local health authority\n13. HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:\n\n    1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n    3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n    4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study NOTE: HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease are excluded.\n14. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n1. Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with controlled CLL must be off all therapy for at least 6 months.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n3. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.\n5. Has had an allogeneic tissue\u002Fsolid organ transplant.\n6. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n8. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n9. Has an active infection requiring systemic therapy.\n10. Has active TB (Bacillus Tuberculosis) infection.\n11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n13. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 7 months (females) or 120 days (males) after the last dose of trial treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n14. Clinically significant cardiovascular disease or cardiac insufficiency (New York Heart Association classes III-IV), cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrollment, angina pectoris within 3 months of enrollment.",{"count":296,"type":20},18,[24],"The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and\u002For resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.",[27],"2026-04-20",{"date":302,"type":34},"2026-04-22",{"date":304,"type":34},"2023-08-03",{"date":306,"type":20},"2028-12",{"name":308,"class":41},"Weill Medical College of Cornell University",3,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":321,"conditions":322,"keywords":332,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":42},"100573965","electrochemotherapy-ect-in-patients-with-primary-visceral-tumors-andor-secondary-visceral-localizations-of-any-histotype-100573965","NCT06753136","Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype","Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation","Inclusion Criteria:\n\n* Male\u002FFemale ≥ 18 years\n* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent\n* Diagnosis of primary and\u002For secondary visceral localizations of any histotype\n* Patients who are not eligible for standard curative procedures\n\nExclusion Criteria:\n\n* Absolute contraindications to invasive procedures\n* Concomitant presence of brain, lung, bone metastases\n* Uncorrectable coagulation changes\n* Bleomycin allergy\n* Absolute contraindications to taking Bleomycin\n* Poor respiratory function or pulmonary fibrosis\n* Acute lung infections\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study",{"count":318,"type":20},24,[320],"NA","This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.\n\nAlthough still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745\u002F2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.",[323,324,325,326,79,327,328,329,27,276,330,331],"Primary Visceral Tumors of Any Histotype","Visceral Lesions","Liver Cancer","Liver Metastasis Colon Cancer","Primary Pancreatic Tumor","Retroperitoneal Sarcoma","Abdominal and\u002For Peritoneal Localizations","Secondary Visceral Localizations of Any Histotype","Non-melanoma Skin Cancer",[333,334,335,336,337,338,339],"electrochemotherapy","visceral lesions","Laparoscopic procedure","Laparotomic procedure","Percutaneous procedure","bleomycin","medical device","2026-04-09",{"date":342,"type":34},"2026-04-13",{"date":344,"type":34},"2025-07-23",{"date":346,"type":20},"2030-02-28",{"name":348,"class":41},"Istituto Oncologico Veneto IRCCS",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":42},"100533272","phase-2-emla-topical-cream-for-treatment-of-pain-in-patients-receiving-intra-dermal-technetium-99-injections-for-lymphoscintigraphy-for-skin-cancers-100533272","NCT06223659","EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers","Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers","Inclusion Criteria:\n\n* Biologic males or females\n* 18 - 99 years of age\n* Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic\n* History of adhesive allergy\n* Contraindication to Tc99 injection for sentinel lymph node mapping\n* Incarcerated patients\n* Patients incapable of independently providing consent\n* Mucosal or genital lymphoscintigraphy site\n* Pregnancy\n* Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis\n* Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):\"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason\" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure",{"count":106,"type":20},[24],"This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.",[360,27,361],"Cutaneous Melanoma","Skin Squamous Cell Carcinoma","2026-03-07",{"date":364,"type":34},"2026-03-10",{"date":366,"type":34},"2023-12-19",{"date":368,"type":20},"2026-10-31",{"name":370,"class":41},"Ohio State University Comprehensive Cancer Center",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":21,"phases":380,"briefSummary":381,"conditions":382,"keywords":396,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":379,"type":20},134,[23,24],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[383,384,385,228,386,387,388,389,390,84,79,27,391,392,393,394,80,82,395,276,277],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Brain Metastases, Adult","Colorectal Cancer","Esophageal Cancer","Esophageal Squamous Cell Carcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Small Cell Lung Cancer",[397,398,262,399,400,401,402,403,404,405,406,407],"Astrocytoma","IDH-mutant","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-02-27",{"date":410,"type":34},"2026-03-02",{"date":412,"type":34},"2023-11-01",{"date":414,"type":20},"2027-08-31",{"name":416,"class":96},"Neonc Technologies, Inc.",6,{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":42},"100477366","phase-2-neoadjuvant-pd-1-blockade-in-resectable-merkel-cell-carcinoma-100477366","NCT05496036","Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma","MCC","Inclusion Criteria:\n\n1. Must have resectable stage I-III MCC.\n2. Must be expected to have an adequate amount of tumor burden to yield 2-4 pre-operative research core biopsy (14-gauge needle) specimens or the equivalent amount of tissue (4-6 mm punch biopsy), in addition, to the tissue required for diagnostic purposes. For stage III MCC patients, assessment of measurable disease\u002Ftumor burden will be determined by tumor imaging and reviewed by the treatment team.\n3. Must be expected to have an adequate amount of residual tumor after their pre-operative research tumor tissue collection, such that their operative research tumor collection will also yield at least 4-6 research core biopsy specimens or the equivalent amount of tissue.\n4. Must be willing to undergo the two paired tumor tissue biopsy procedures to obtain samples for biomarker analysis. Tissue obtained must not be previously irradiated.\n5. Male subjects must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female subjects must not be pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided.\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n9. Have adequate organ function.\n10. Hepatitis B (HBV) positive subjects\n\n    * Subjects who is HBsAg positive is eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n    * Subject should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n11. Subject with history of Hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening. Subject must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nExclusion Criteria:\n\n1. Have unresectable disease; i.e. in the opinion of the surgical oncologist, all of the subject's MCC cannot be completely removed with a clear margin.\n2. If the subject had major surgery, the subject must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention\n3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.\n4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n5. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.\n6. Has received prior radiotherapy within 2 weeks of start of study intervention. Subject must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n7. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n10. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Subject with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n11. Has known active CNS metastases and\u002For carcinomatous meningitis. Subject with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n12. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n13. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n14. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n15. Has an active infection requiring systemic therapy.\n16. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n17. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n18. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n21. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":426,"type":20},15,[24],"The main purpose of this study is to determine the response of Merkel cell carcinoma to pembrolizumab before surgery and to determine whether it further reduces the risk for disease recurrence. Another purpose of this study is to look at the side effects that occur when the experimental drug pembrolizumab is given to people with Merkel cell carcinoma before and after their standard of care surgery to remove the Merkel cell carcinoma.",[27],"2026-02-17",{"date":432,"type":34},"2026-02-18",{"date":434,"type":34},"2023-02-13",{"date":436,"type":20},"2027-09-30",{"name":438,"class":41},"Abramson Cancer Center at Penn Medicine",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":21,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":42},"100527705","phase-2-neoadjuvant-nivolumab-and-relatlimab-in-merkel-cell-carcinoma-100527705","NCT06151236","Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma","A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma","Inclusion Criteria:\n\n1. Aged ≥ 18 years\n2. Written consent\n3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease\n4. In-transit metastases are permitted if they are completely resectable\n5. Measurable disease according to RECIST 1.1 criteria\n6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy\n7. At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and\u002For a newly obtained core biopsy of a lesion which has not been previously irradiated.\n8. ECOG 0-1\n9. Adequate organ function on blood pathology\n10. Life expectancy \\>12 months\n11. Female patients to use effective contraception during study treatment and for 5 months after last dose.\n\nExclusion Criteria:\n\n1. Clinical, radiographic or pathological evidence of distant metastases\n2. Contraindication to nivolumab and \u002F or relatlimab\n3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment\n4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy\n5. A diagnosis of immunodeficiency or chronic steroid therapy \\>10 mg OD prednisone or equivalent\n6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.\n7. Uncontrolled cardiovascular disease or history of myocarditis\n8. Has had an allogenic tissue\u002Fsolid organ transplant\n9. Troponin T (TnT) or I (TnI) \\>2 × institutional ULN\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease\n11. Has an active infection requiring systemic therapy\n12. Active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n13. Known HIV\n14. Pregnant or breast feeding females\n15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule",{"count":447,"type":20},20,[24],"The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival",[27],"2026-02-12",{"date":430,"type":34},{"date":454,"type":34},"2024-03-11",{"date":456,"type":20},"2034-04",{"name":458,"class":41},"Melanoma Institute Australia",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":21,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":42},"100615089","phase-2-til-therapy-in-cscc-and-mcc-100615089","NCT07288073","TIL Therapy in cSCC and MCC","A Feasibility Study of Tumor Infiltrating Lymphocytes in Cutaneous Squamous Cell Carcinoma and Merkel Cell Carcinoma","Inclusion Criteria:\n\n* Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written authorization for use and disclosure of protected health information.\n* Patients must be ≥ than 18 years of age at the time of signing the informed consent form.\n* Patients must have histologically or pathologically confirmed diagnosis of CSCC or MCC. Note: Mixed histology is allowed. Note: Neuroendocrine cancer that is clinically considered to be related to a cutaneous primary (MCC) or induced by sun damage (per investigator assessment) is allowed.\n* Patients must have unresectable, recurrent, or metastatic disease.\n* Patients must have a documented radiographic or clinical disease progression after treatment with ICI (including anti-PD-1 and anti-PD-L1) if it is used in the palliative setting. In patients who received ICI in the neoadjuvant or adjuvant setting, recurrence should have occurred within 6 months from the last treatment with ICI.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 in the investigator's opinion (Appendix B).\n* Patients must have at least 1 resectable lesion (or aggregate lesions) with an expected minimum of 1.5 cm diameter in the short axis for TIL production. Note: If a lesion that is considered for TIL harvest is within a previously irradiated field, the lesion must have demonstrated radiographic or clinical progression prior to harvest, and the irradiation must have been completed at least 6 months prior to enrollment.\n* Patients must be expected to have at least 1 remaining measurable lesion as defined by RECIST v1.1 or evaluable (radiographically or on clinical examination) following tumor harvest for TIL manufacturing and production that is documented at screening with the following considerations:\n\n  * Lesions in a previously irradiated areas should not be selected as target lesions unless progression has been demonstrated in those lesions and the irradiation has been completed at least 6 months prior to enrollment.\n  * Patients who have only one site of disease may be enrolled if they have a lesion th can be partially resected for TIL harvest, and the remaining portion of the lesion is measurable or evaluable.\n* Patients must have the following hematologic parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002FdL and have not received transfusion of packed red blood cells within 7 days.\n  * Platelet count ≥ 100,000\u002Fmm3\n* Patients must have an adequate organ function with the following laboratory test values:\n\n  * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); and for patients with liver metastases ≤ to 5 times ULN.\n  * Total bilirubin ≤ 2 mg\u002FdL; patients with Gilbert's Syndrome ≤ to 3 mg\u002FdL.\n  * Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening.\n* Patients must have a left ventricular ejection fraction (LVEF) ≥ 45% and be New York Heart Association (NYHA) Class 1 or 2. A cardiac stress test is required for patients who have significant ischemic heart disease, or clinically significant unstable arrythmias; the cardiac stress test must demonstrate no irreversible wall movement abnormality. Patients with an abnormal cardiac stress test may be enrolled if they have adequate ejection fraction and cardiology clearance.\n* Patients must have adequate pulmonary function within 2 months from enrollment.\n\nPatients require pulmonary function testing (PFT) if they have any of the following:\n\n* History of cigarette smoking of ≥ 20 pack-years\n* Ceased smoking within the past 2 years or still smoking.\n* History of chronic obstructive pulmonary disease (COPD)\n* Any signs or symptoms of significant respiratory dysfunction.\n\nPost-bronchodilator required pulmonary test results:\n\n* Forced expiratory volume (FEV1)\u002F forced vital capacity (FVC) \\> 70%. Or\n* FEV1 \\> 50% of predicted normal value. Note: If a patient is unable to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function. Patients must be able to walk a distance at least 80% of predicted for age and sex with no evidence of hypoxia at any point during the test (i.e., saturation of peripheral oxygen \\[SpO2\\] must remain ≥ 89%).\n\n  * Patients must have completed or discontinued systemic therapy ≥ 21 days prior to tumor harvest. Note: Patients are allowed to have palliative radiation or systemic therapy after tumor harvest and before NMA-LD but there should be at least 7 days between discontinuation of palliative treatment and start of NMA-LD.\n  * Patients must have recovered from all prior anticancer TRAEs to Grade ≤ 1 (per CTCAE v5.0) with the exceptions of vitiligo, alopecia or neuropathy. Patients with irreversible toxicity that are properly managed (such as with endocrinopathy treatment with hormone replacement therapy) may qualify for the study regardless of grade of TRAEs.\n  * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving all protocol-related therapy (Appendix C). Additionally, males may not donate sperm and females may not donate eggs during the required contraception period.\n\nApproved methods of birth control include:\n\n* Combined (estrogen- and progesterone- containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal.\n* Progesterone-only hormonal birth control associated with inhibition of ovulation:\n\noral, injectable, implantable.\n\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomy\n* True absolute sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) is not acceptable.\n\nExclusion Criteria:\n\n* Have a history of allogenic organ transplant.\n* Have symptomatic untreated brain metastases. Patients with brain metastases may be enrolled with the following considerations:\n\n  * Patients with asymptomatic brain metastases that are treated and have been stable for at least 7 days may be enrolled.\n  * Patients with historically or recently treated brain metastases will be considered for enrollment if the patient is clinically stable for ≥ 2 weeks, and the patient does not require ongoing corticosteroid treatment (\\>10 mg\u002Fday prednisone or its equivalent).\n  * Patients who undergo tumor harvest prior to disease progression and develop symptomatic brain metastases after tumor harvest should have receive appropriate treatment for ≥ 2 weeks and not require corticosteroids (\\>10 mg\u002Fday or its equivalent) at the start of NMA-LD (Day -5).\n* Require systemic steroid therapy \\>10 mg\u002Fday prednisone or its equivalent. Patient receiving steroids as replacement therapy for adrenocortical insufficiency are not excluded.\n* Have evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment.\n* Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta human chorionic gonadotropin (B-HCG) test at Screening (Appendix C).\n* Have active medical illness that in the opinion of the investigator would pose increased risk for study participation, such as systemic infections, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.\n* Have received a live or attenuated vaccination within 28 days prior to the start of NMALD.\n* Have any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \\[SCID\\] or acquired immune deficiency syndrome \\[AIDS\\]).\n* Have a history of allogenic stem cell transplant, or active hematological malignancy (such as chronic lymphocytic leukemia or lymphoma).\n* Have a history of hypersensitivity to any component of the study drugs. TIL should not be administered to patients with a known hypersensitivity to any component of the autologous TIL product formulation including, but not limited to, any of the following:\n\n  * NMA-LD (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin, aldesleukin, IL-2\n  * Antibiotics of the aminoglycoside group. These patients may be eligible if current hypersensitivity has been excluded.\n  * Any component of the TIL product formulation, including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, or dextran-40\n* Have had another primary malignancy within the previous 1 year (except for malignancies that do not require treatment or have been curatively treated, and do not pose a significant risk of recurrence including, but not limited to in situ carcinoma of the cervix, early stage skin cancer, including non-melanoma skin cancer; ductal carcinoma in situ (DCIS) or lobular carcinoma in the situ (LCIS) of the breast; intraductal carcinoma of the breast that has been treated with curative intent including patients who are on adjuvant hormonal treatment, prostate cancer with Gleason score ≤ to 6; or superficial bladder cancer).",{"count":467,"type":20},14,[24],"The purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy.\n\nThe names of the study interventions involved in this study are:\n\n* Tumor Infiltrating Lymphocytes (a type of cellular therapy)\n* Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs)\n* Interleukin-2 (a type of recombinant, human glycoprotein)",[55,27,471,57],"Metastatic Cutaneous Squamous Cell Carcinoma",[55,27,471,57],"2026-02-11",{"date":475,"type":34},"2026-02-13",{"date":477,"type":34},"2026-02-10",{"date":479,"type":20},"2029-06-29",{"name":481,"class":41},"Karam Khaddour, MD, MS",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":21,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":42},"100446950","phase-2-hypofractionated-radiation-therapy-for-merkel-cell-carcinoma-100446950","NCT05100095","Hypofractionated Radiation Therapy for Merkel Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed MCC.\n* Patients must have no evidence of distant metastasis as determined by clinical examination and any form of imaging.\n* If planned for adjuvant primary tumor radiation therapy a patient should have had surgical excision of a primary MCC tumor within 4 months of starting RT.\n* If planned for adjuvant nodal radiation therapy a patient should have had:\n\n  * Prior positive sentinel lymph node biopsy with any degree of nodal involvement within 4 months of starting RT and no completion nodal dissection, or\n  * Lymph node dissection within 4 months of starting RT and high risk nodal disease (receipt of neoadjuvant immunotherapy, ECE, \\>1 involved node, \\>1 cm nodal disease).\n* Immunotherapy is permitted at any time and may specifically be administered prior to RT, concurrent with RT or after RT.\n* Age ≥18 years because MCC is extremely rare in patients \\\u003C18 years of age and RT is considered high risk in this population due to risk of secondary malignancy and potentially growing tissues that may be adversely impacted by RT.\n* ECOG performance status ≤3.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* RT is a known teratogen. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (refer to MDA Policy CLN 1114) This includes all female patients, between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: • Postmenopausal (no menses in greater than or equal to 12 consecutive months). • History of hysterectomy or bilateral salpingo-oophorectomy. • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). • History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of RT.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExpansion cohort\n\n• Patient would have received \\\u003C50.4 Gy using conventional radiotherapy dose-fractionation if not enrolled.\n\nExclusion Criteria:\n\n* Previous radiation therapy to the site of planned primary or nodal radiation treatment such that the prior site of treatment would be encompassed by the radiation field needed to treat the current cancer. In other words, treatment on this trial would require re-irradiation of tissues.\n* Patients with distant metastases\n* Pregnant women are excluded from this study because RT is a known teratogen.\n* Patients who are less than 18 years of age becase RT is extremely rare in this population and the treatment agent is a known carcinogen.",{"count":489,"type":20},52,[24],"This phase II trial tests whether hypofractionated radiation works to treat patients with Merkel cell carcinoma. Radiation therapy uses high energy radio waves to kill cancer cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may be more convenient for patients and less immunosuppressive.",[27],"2026-01-13",{"date":495,"type":34},"2026-01-14",{"date":497,"type":34},"2021-12-14",{"date":499,"type":20},"2028-09-01",{"name":124,"class":41},{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":510,"briefSummary":511,"conditions":512,"keywords":524,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":178},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":509,"type":20},56,[23],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[55,513,253,514,515,79,27,516,517,518,84,519,520,521,522,138,139,523,137],"SCC - Squamous Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[55,513,253,514,79,27,516,517,518,84,519,520,521,522,138,139,523,525,177,526,137],"MQ710","22-278","2025-12-02",{"date":529,"type":34},"2025-12-03",{"date":531,"type":34},"2023-05-04",{"date":533,"type":20},"2028-05-04",{"name":177,"class":41},{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":309},"100557295","personalised-immunotherapy-platform-100557295","NCT06536257","Personalised Immunotherapy Platform","Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma","PIP-PREDICT","MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue, blood and stool and collection of standard clinical data.\n2. Histologically confirmed resected stage II (at high risk of recurrence of disease), III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal or unknown primary melanoma) and unresectable Stage III or IV melanoma\n3. Eligible to receive immunotherapy\n4. Availability of a melanoma tissue sample which was obtained at surgery and where no systemic treatments (e.g. adjuvant treatment) were administered between sample procurement and proposed PIP testing\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease\n6. RECIST version 1.1 measurable disease.\n7. Tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with BRAF (B-Raf proto-oncogene) \u002F MEK (mitogen-activated protein kinase) inhibitors are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field.\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required\n\nNON-MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue and collection of standard clinical data\n2. Histologically confirmed cancer and eligibility to receive immunotherapy treatment.\n3. Availability of a tissue sample where no systemic treatments were administered between sample procurement and proposed PIP testing\n4. If treatment has been administered since the last tissue sample was obtained, a new biopsy should be planned for routine testing or clinical trial screening, where a portion of the sample can be used for the predictive assay. No new biopsies are required for the sole purpose of this study.\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease.\n6. Have clinically detectable disease defined as one of more of the following:\n\n   * RECIST measurable. Lesions situated in a previously irradiated area are considered measurable if RECIST-defined disease progression since radiotherapy has been demonstrated in such lesions, OR,\n   * Positron Emission Tomography (PET) avid, OR,\n   * Clinically evident disease: photographically, detectable on CT or palpable, OR\n   * Clinical status measured by observable and diagnosable signs or symptoms.\n7. The tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with targeted therapies are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required",{"count":544,"type":20},1000,"This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.",[79,55,253,27,137],[548,549,550,551,552,553,554,555,556,557,558],"Biomarker","Predictive","Immunotherapy","Multi-omic","Tumour mutation burden","Gene expression","Tissue imaging","Machine learning","Multiplex immunofluorescence","Immune checkpoint inhibitors","Quantitative pathology","2025-09-12",{"date":561,"type":34},"2025-09-18",{"date":563,"type":34},"2021-06-08",{"date":565,"type":20},"2037-06-01",{"name":458,"class":41},{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":21,"phases":577,"briefSummary":578,"conditions":579,"keywords":605,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":248},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":576,"type":20},115,[23,24],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[580,581,582,83,583,584,585,389,228,253,225,27,586,55,587,387,259,137,588,589,590,591,592,593,594,595,360,596,597,598,599,600,601,57,602,603,604],"Advanced Solid Tumor","Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Squamous Cell Carcinoma of Head and Neck","Pleural Mesothelioma","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Viral Cancer","Cervical Cancers","Endometrial Cancer",[606,607,608,609,610,611,612,613,614,615,616,617,423,618,619,620,621,622,623,624,625,626,627,628,629,514,630,631,632,633,634],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":637,"type":34},"2025-07-09",{"date":639,"type":34},"2021-08-27",{"date":641,"type":20},"2026-12-30",{"name":643,"class":96},"Medicenna Therapeutics, Inc.",{"id":645,"slug":646,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":21,"phases":654,"briefSummary":656,"conditions":657,"keywords":662,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":133},"100445254","phase-3-study-comparing-the-standard-administration-of-io-versus-the-same-io-administered-each-3-months-in-patients-in-response-after-6-months-of-standard-io-100445254","NCT05078047","Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO","Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO","MOIO","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures.\n2. Patient aged ≥18 years old.\n3. Metastatic disease (or locally advanced disease not suitable for local treatment) of initial tumor histologically confirmed including: lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite instability \\[MSI\\], esophageal squamous cell carcinoma, endometrial carcinoma,cervical cancer, gastric\u002Fgastro-oesophageal junction adenocarcinoma, basal cell carcinoma or squamous skin carcinoma.\n4. Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST or PERCIST v1.0 criteria (confirmed by local radiological assessment).\n\n   For metastatic melanoma only patients in partial response. Patients with metastatic or advanced cancer treated by immunotherapy as maintenance therapy can be included without any lesion at IO initiation. In this case, response after 6 months of standard immunotherapy will be evaluated by the non-appearance of a new lesion.\n5. Eligible to maintain the same standard IO treatment.\n6. Patient with Eastern cooperative oncology group (ECOG) performance status ≤1.\n7. Patients with brain metastases are allowed, provided they are stable according to the following definitions: treated with surgery or stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.\n8. Patients treated by IO previously combined with chemotherapy are allowed.\n9. Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IO are allowed.\n10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients.\n11. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use adequate contraception method for the duration of the study treatment and after completing treatment according to the most recent version of the IO Summary of product characteristics (SmPC).\n12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n13. Patient must be affiliated to a Social Security System.\n\nExclusion Criteria:\n\n1. Metastatic melanoma in complete response.\n2. Metastatic renal cell carcinoma with International Metastatic Renal Cell Carcinoma Database (IMDC) favourable-risk treated TKI\u002FIO combination.\n3. Hematologic malignancies (leukaemia, myeloma, lymphoma…)\n4. Active infection requiring systemic therapy.\n5. Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.\n6. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study.\n7. Person deprived of their liberty or under protective custody or guardianship.",{"count":653,"type":20},646,[655],"PHASE3","Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.",[658,82,142,83,27,265,79,277,659,388,259,228,660,253,661],"Lung Cancer Metastatic","Colorectal Carcinoma With Microsatellite Instability","Gastric\u002FGastro-esophageal Junction\u002FEsophageal Adenocarcinoma","Squamous Skin Carcinoma",[550],"2025-06-04",{"date":665,"type":34},"2025-06-05",{"date":667,"type":34},"2022-03-08",{"date":669,"type":20},"2027-03-07",{"name":671,"class":41},"UNICANCER",{"id":673,"slug":674,"hasResults":11,"nctId":675,"briefTitle":676,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":678,"phases":4,"briefSummary":679,"conditions":680,"keywords":683,"overallStatus":694,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":698,"locationsCount":4},"100428020","ifx-hu20-expanded-access-program-100428020","NCT04853602","IFx-Hu2.0 Expanded Access Program","Inclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record\n\nExclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record","EXPANDED_ACCESS","Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.\n\nTo request access, use Responsible Party contact information provided in this record..",[681,682,27,55],"Cutaneous Melanoma, Stage III","Cutaneous Melanoma, Stage IV",[684,423,685,686,687,688,689,550,690,691,692,693],"CM","cSCC","pDNA","plasmid DNA","pAc\u002Femm55","IFx-Hu.20","Gene Therapy","Immunology","Oncology","Immuno-Oncology","AVAILABLE","2024-08-08",{"date":697,"type":34},"2024-08-12",{"name":699,"class":96},"TuHURA Biosciences, Inc.",{"id":701,"slug":702,"hasResults":11,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":709,"conditions":710,"keywords":711,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":713,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":720,"locationsCount":4},"100550556","identification-and-characterization-of-circulating-tumor-cells-before-and-after-treatment-surgery-and-radiotherapy-in-a-cohort-of-patients-treated-for-resectable-stage-i-iii-merkel-cell-carcinoma-100550556","NCT06448611","Identification and Characterization of Circulating Tumor Cells Before and After Treatment (Surgery and Radiotherapy) in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma","Identification and Characterization of Circulating Tumor Cells Before and After Treatment in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma","MERCCALIBI","Inclusion Criteria:\n\n* Patients at least 18 years old\n* Patients managed for stage I to III Merkel cell carcinoma,\n* For whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Failure to obtain written informed consent after a reflection period\n* Participant in another research study with an ongoing exclusion period\n* Not affiliated to a social security scheme\n* Persons under court protection\n* Patients unable to give consent, protected adults, vulnerable persons\n* Stage IV disease or stage I to III disease for which complete remission is not envisaged",{"count":5,"type":20},"The goal of this prospective observational study is to evaluate the presence of circulating tumoral cells in patients over 18 with a stage I-III resectable Merkel cell carcinoma after the initial therapeutic sequence of surgery and radiotherapy. The main question it aims to answer is :\n\nCan any residual disease be found in the form of circulating tumoral cells in blood samples of patients treated with surgery and radiotherapy for a resectable, stage I to III Merkel cell carcinoma ? When possible, the circulating tumoral cells count will be compared to the one realized in a blood sample of the same patient before surgery and radiotherapy.\n\nParticipants will :\n\n* Have a blood sample taken before surgery (if the patient is addressed to our center early enough),\n* Have a blood sample taken immediately after surgery and radiotherapy (for all).\n* Two additional blood samples will be taken during the 6-months and 12-months visit to set up a biobank.",[27],[712],"Circulating Tumor Cells","2024-06-11",{"date":715,"type":34},"2024-06-13",{"date":717,"type":20},"2024-07-01",{"date":719,"type":20},"2027-06-01",{"name":721,"class":41},"University Hospital, Montpellier",{"id":723,"slug":724,"hasResults":11,"nctId":725,"briefTitle":726,"officialTitle":727,"acronym":728,"eligibilityCriteria":729,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":730,"targetDuration":4,"studyType":21,"phases":732,"briefSummary":733,"conditions":734,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":309},"100522720","phase-2-study-of-pembrolizumab-combined-with-cisplatin-or-carboplatin-and-etoposide-in-treatment-nave-advanced-merkel-cell-carcinoma-mcc-100522720","NCT06086288","Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC)","Phase II, Open Label, Single Arm Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC) (PANDORA Trial)","PANDORA","Inclusion Criteria:\n\n1. Male\u002Ffemale subjects with histologically confirmed diagnosis of MCC, who have not received prior systemic treatment for their advanced or metastatic MCC, are at least 18 years of age on the day of signing informed consent, will be enrolled in this study.\n2. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatments (e.g. 5 terminal half-lives for pembrolizumab and\u002For any active comparator\u002Fcombination) plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.\n\n   Female participants:\n3. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatments (pembrolizumab and\u002For any active comparator\u002Fcombination) plus 30 days (a menstruation cycle) after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Unresectable and locally advanced, relapsed or metastatic MCC stage IIIB-IV according to American Joint Committee on Cancer (AJCC) TNM Staging Classification for Merkel Cell Carcinoma (8th ed. 2017)\n6. No prior systemic treatment for metastic MCC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant\u002Fneoadjuvant therapy was completed at least 12 months prior to the onset of metastatic disease.\n7. Have a life expectancy of at least 3 months.\n8. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n9. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n11. Have adequate organ function (protocol table 4)\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n3. Has received prior systemic anti-cancer therapy.\n4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n9. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n15. Has a known history of active Hepatitis B (defined as HBV DNA is detected) or known active Hepatitis C virus (defined as HCV RNA quantitative is detected) infection.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n19. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":731,"type":20},35,[24],"This is an open label, multicenter, phase II study evaluating the activity and safety of pembrolizumab combined with cisplatin\u002Fcarboplatin and etoposide as first line treatment in patients with advanced MCC.",[27],"2023-10-10",{"date":737,"type":34},"2023-10-17",{"date":739,"type":20},"2023-11",{"date":741,"type":20},"2027-12",{"name":743,"class":41},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":745,"slug":746,"hasResults":11,"nctId":747,"briefTitle":748,"officialTitle":749,"acronym":4,"eligibilityCriteria":750,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":751,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":753,"conditions":754,"keywords":755,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":756,"lastUpdatePostDateStruct":757,"startDateStruct":759,"completionDateStruct":761,"leadSponsor":763,"locationsCount":42},"100519091","exploring-merkel-cell-carcinoma-clinical-trial-engagement-patterns-100519091","NCT06039033","Exploring Merkel Cell Carcinoma Clinical Trial Engagement Patterns","Merkel Cell Carcinoma Clinical Trials: What Are Prevailing Patient Experiences in Merkel Cell Carcinoma Studies","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n* Diagnosis of Merkel cell carcinoma\n\nExclusion Criteria:\n\n* No diagnosis of Merkel cell carcinoma confirmed\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form",{"count":752,"type":20},500,"Taking part in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.\n\nThis study will admit a wide range of data on the clinical trial experience of Merkel cell carcinoma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Merkel cell carcinoma patients.",[27],[27],"2023-09-08",{"date":758,"type":34},"2023-09-15",{"date":760,"type":20},"2024-10",{"date":762,"type":20},"2026-10",{"name":764,"class":96},"Power Life Sciences Inc."]