[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-squamous-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,43,65,94,127,154,177,206,241,272,295,320,342,367,404,436,471,551,574,606,626,653,680],{"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":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"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",false,"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.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27],"Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma",[29],"Skin Cancer","RECRUITING","2026-06-24",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":34},"2021-10-22",{"date":38,"type":20},"2028-03",{"name":40,"class":41},"H. Lee Moffitt Cancer Center and Research Institute","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":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100559682","phase-2-phase-2-study-of-ivonescimab-in-patients-with-cutaneous-squamous-cell-carcinoma-100559682","NCT06567314","Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma","Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma and Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.\n* Age ≥18 years.\n* Has locally advanced surgically non-appropriate (unresectable and\u002For metastatic) cSCC (Cohort 1)..\n* Has metastatic CRPC (Cohort 2):\n\n  * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n  * Documented prostate cancer progression as documented by PSA progression according to PCWG3 criteria.\n  * Surgically or medically castrated, with serum testosterone level \\\u003C50 ng\u002FdL.\n* Refractory or naïve to anti-PD-1 therapy (Cohort 1). There is no limit on the number of prior lines of therapy. NOTE: Detailed information regarding duration of prior anti-PD-1 therapy and the extent of progression at the time of anti-PD-1 therapy discontinuation will be collected.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).\n* Cohort 1: measurable disease per the RECIST v1.1 or Measurable by mRECIST for skin cancer or Global Assessment or Papillary\u002FUlceration Response Assessment or Pathological Assessment or WHO Criteria for Response Assessment in Cutaneous Squamous Cell Carcinoma, as appropriate (Appendix 4).\n* Adequate organ and marrow function as defined below within 28 days of study treatment initiation:\n\n  * Hemoglobin \\>9.0 g\u002FdL\n  * Absolute neutrophil count ≥1500\u002FmL\n  * Platelets ≥100,000\u002FmL\n  * Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n  * AST\u002Falanine transaminase ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.\n  * Serum creatinine ≤1.5 × ULN OR measured or calculated creatinine clearance (CrCl; glomerular filtration rate can also be used in place of creatinine or CrCl) ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 × institutional ULN (CrCl should be calculated per institutional standard).\n  * Urine protein \\\u003C2+ or 24-hour urine protein quantification \\\u003C1.0 g\n  * For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n  * Albumin \\>2.5 mg\u002FdL.\n* Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); 4 weeks from radiation therapy; and at least 2 weeks from palliative radiotherapy.\n* Prior treatment with anti-VEGF therapy is allowed (Cohort 1).\n* Adequately controlled blood pressure with 0 or 1 antihypertensive medication (defined as blood pressure ≤150\u002F100 mmHg at screening and no changes in antihypertensive medication within 7 days of Day 1 Cycle 1.\n* Women of childbearing potential (WOCBP) should have a negative urine or serum pregnancy within 72 hours prior to study treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* WOCBP must agree to use adequate contraception during the study treatment period and for 120 days after completion of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). 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* Male participants of childbearing potential must agree to use adequate contraception during the study treatment period and for 120 days after completion of study treatment.\n\nExclusion Criteria:\n\n* Patients who have previously been treated with PD-1\u002FPD-L1 inhibitors and required permanent discontinuation, or systemic immunosuppression due to irAEs.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab.\n* Pregnant or breastfeeding.\n* Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.\n* Known history of acute or chronic hepatitis B virus or hepatitis C virus infection.\n* Previous solid organ or allogeneic hematopoietic stem cell transplant.\n* Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n* Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.\n* Major blood vessel invasion.\n* Major surgical procedures or serious trauma within 4 weeks prior to study treatment initiation, or plans for major surgical procedures within 4 weeks after the first dose of study treatment (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification Grade ≥2) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.\n* History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment initiation.\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to study treatment initiation.\n* Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Inability to comply with the study and follow-up procedures.\n* Participants who are receiving any other investigational agents.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":51,"type":20},24,[53],"PHASE2","To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.",[27],"2026-06-09",{"date":58,"type":34},"2026-06-11",{"date":60,"type":34},"2024-12-02",{"date":62,"type":20},"2030-09-01",{"name":64,"class":41},"M.D. Anderson Cancer Center",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"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":73,"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.",[77,78,79,80,27,26,81,82,83,84],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Melanoma","Pancreatic Cancer","Triple Negative Breast Cancer","Head and Neck Cancer",{"date":58,"type":34},{"date":87,"type":34},"2022-04-21",{"date":89,"type":20},"2031-12",{"name":91,"class":92},"Memgen, Inc.","INDUSTRY",2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":114,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":42},"100638760","phase-1-a-study-of-idp-001-in-advanced-or-metastatic-solid-tumors-100638760","NCT07602842","A Study of IDP-001 in Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Measurable disease per RECIST v1.1\n* Participant willing to provide tumor biopsies\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n* Life expectancy greater than 12 weeks\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Any clinically significant corneal disorder\n* Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Active significant neurologic disorders\n* Requires home oxygen\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* History of major immunologic reaction to prior immunoglobulin G-containing agent\n* Clinically significant ascites or liver disease\n* Uncontrolled diabetes or diabetic neuropathy\n* Active bleeding disorders\n* Participation in a concurrent clinical study in the treatment period\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to IDP-001 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Has had a seizure prior to Screening\n* Prior solid organ transplant or allogeneic stem cell transplant\n* Current endocrinopathy\n* History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis\n* History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids\n* Stroke or transient ischemic attack prior to Screening\n* Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":102,"type":20},132,[23,53],"This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).",[106,107,108,27,109,110,111,112,113],"Advanced Solid Tumor","Metastatic Solid Tumor","Head and Neck Squamous Cell Carcinoma","Squamous Cell Carcinoma of the Cervix","Non Squamous Non Small Cell Lung Cancer","Squamous Cell Carcinoma of the Esophagus","Squamous Cell Carcinoma of the Anus","Squamous Cell Carcinoma",[115,116],"NSCLC","Squamous NSCLC","NOT_YET_RECRUITING","2026-05-19",{"date":120,"type":34},"2026-05-22",{"date":122,"type":20},"2026-06",{"date":124,"type":20},"2028-12",{"name":126,"class":92},"InduPro, Inc.",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":42},"100468294","phase-1-microneedle-array-plus-doxorubicin-in-cutaneous-squamous-cell-cancer-cscc-100468294","NCT05377905","Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)","Phase Ib\u002FII Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma","cSCC","Inclusion Criteria:\n\n1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.\n2. Subjects must have resectable stage I-III disease.\n\n   \\- Measures ≥5 millimeters (mm; post-biopsy) and \\\u003C100 mm in longest diameter\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n4. Subjects must have an expected survival of greater than or equal to 12 months.\n5. Subjects must not be on any other investigational device\u002Fdrug treatment.\n6. Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.\n7. Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500\u002Fmm3; platelets \\>50,000\u002Fmm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3X ULN.\n8. Subjects must be at least 18 years of age and must be able to understand the written informed consent\u002Fassent document.\n9. Subjects must have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment.\n10. Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.\n11. Subjects with multiple cSCC may re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion\u002Fexclusion criteria are met.\n12. Patients with HIV infection with CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL will be eligible for the study. Patients without a history of AIDS-defining opportunistic infections will be eligible for the study.\n13. Subjects must be willing\u002Fable to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.\n\nExclusion Criteria:\n\n1. Subjects with the following tumor characteristics:\n\n   * \\>4 mm depth;\n   * Clark level IV;\n   * perineural invasion, lymphovascular invasion;\n   * primary site on the ear or non-glabrous lip;\n   * location in the hands or feet;\n   * large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;\n   * indistinct borders;\n   * rapid growth;\n   * recurrent lesion;\n   * lesion in site of chronic inflammation or prior radiation therapy;\n   * presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes.\n2. Subjects with uncontrolled pain that would preclude participation in the study.\n3. Subjects who are pregnant or lactating.\n4. Subjects who have sensitivity to drugs that provide local anesthesia.\n5. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n   * Symptomatic congestive heart failure requiring treatment\n   * Clinically significant cardiac arrhythmia\n   * Uncontrolled hypertension\n   * Corrected QT interval (QTc) \\>470 msec at Screening or congenital long QT syndrome\n   * Acute myocardial infarction or unstable angina pectoris \\\u003C 3 months prior to the first dose\n   * New York Heart Association Functional Class III or higher (i.e. marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort)\n6. Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.\n7. Active, known, or suspected autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma\u002Fatopy.\n\n   • Individuals with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, history of Hashimoto's thyroiditis on stable dose of thyroid hormone replacement therapy, adrenal insufficiency only requiring physiologic steroid replacement, or conditions not expected to recur should not be excluded.\n8. Major surgery within 2 weeks of the first dose of study agent\n9. History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2\n10. Subjects with the disease only on the face, skin folds, head, scalp, and genital area.",{"count":136,"type":20},48,[23,53],"The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.",[27,140],"Skin Cancers - Squamous Cell Carcinoma",[142,143,144],"micro-needle array","doxorubicin","patch","2026-04-03",{"date":147,"type":34},"2026-04-09",{"date":149,"type":34},"2023-09-13",{"date":151,"type":20},"2027-12-31",{"name":153,"class":41},"Falo, Louis, MD",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":165,"phases":4,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":93},"100492674","cutaneous-squamous-cell-carcinoma-staging-study-100492674","NCT05695222","Cutaneous Squamous Cell Carcinoma Staging Study","Comparison of the Prognostic Capacity of Existing Staging Systems for Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Over 18 years old with diagnosis of CSCC\n\nExclusion Criteria:\n\n* Patients who decline for their data to be used for research purposes",true,"120 Years",{"count":164,"type":20},1500,"OBSERVATIONAL","Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer, and one of the most common cancers worldwide. The majority of CSCCs are easily removed by surgery and have excellent prognosis. However, a small subset has poor outcomes, including secondary spread in the body (metastasis) and death.\n\nThe investigators will look at existing CSCC in people from two UK dermatology centres. The investigators will then evaluate the accuracy of current staging systems in predicting risk of poor outcomes in people. The investigators hope that this project will improve the management of patients with CSCC by validating the predictive power of currently available histological staging classifications for cSCC. In the second stage of the study, The investigators will see whether better prediction tools can be found.",[27],"2026-04-01",{"date":170,"type":34},"2026-04-02",{"date":172,"type":34},"2023-05-01",{"date":174,"type":20},"2028-06-05",{"name":176,"class":41},"Queen Mary University of London",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":165,"phases":4,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":42},"100583383","ctdna-in-cutaneous-squamous-cell-carcinoma-100583383","NCT06875609","ctDNA in Cutaneous Squamous Cell Carcinoma","ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma","Post-Operative Cohort\n\nInclusion Criteria:\n\n* Patients with surgically resectable primary CSCC with PNI (\\>0.1mm caliber nerve) or at least 2 high-risk features defined as size \\> 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and\u002For invasion \\>6mm\u002Fbeyond subcutaneous fat;\n* Patients with surgically resectable regional metastases not receiving neoadjuvant therapy\n\nExclusion Criteria:\n\n* Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection\n* Patients receiving or undergoing systemic therapies.\n\nNeoadjuvant Cohort\n\nInclusion Criteria:\n\n* Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.\n\nExclusion Criteria:\n\n* Patients ineligible for neoadjuvant treatment.\n\nDefinitive Immunotherapy Cohort\n\nInclusion Criteria:\n\n* Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.\n\nExclusion Criteria:\n\n* Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.",{"count":185,"type":20},60,"The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.",[27],[189,190,191,192,193,194,195,196],"Circulating Tumor DNA","CSCC","Skin cancer","Biomarker","ctDNA","Minimal Residual Disease (MRD)","Liquid Biopsy","Advanced Skin Cancer","2026-03-26",{"date":199,"type":34},"2026-03-30",{"date":201,"type":34},"2025-03-24",{"date":203,"type":20},"2029-04-30",{"name":205,"class":41},"Massachusetts Eye and Ear Infirmary",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100529282","phase-1-phase-i-study-of-tolododekin-alfa-ank-101-in-advanced-solid-tumors-100529282","NCT06171750","Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","ANCHOR","Inclusion Criteria:\n\n* ≥ 18 years of age on day of signing informed consent\n* histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible\n* measurable disease per RECIST v1.1 - Note: Must have at least 1 tumor lesion with longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node lesions) that - For Part 1 only: can be easily palpated or detected by ultrasound to facilitate IT injection of ANK-101 (i.e., tumor in skin, muscle, subcutaneous tissue, or accessible lymph node) or; - For Part 2 only: can be accessed by interventional radiologic or endoscopic procedures for injection (e.g., ultrasound or computed tomography \\[CT\\] guided). - For Part 2 Dose Expansion Cohort only: Histologically confirmed Stage III or Stage IV NSCLC\n* Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic CSCC not amenable to surgical management as determined by a multidisciplinary tumor board.\n* documented disease progression, be refractory to, or intolerant of existing SOC therapy(ies) known to provide clinical benefit (including surgical cure) or not be eligible for SOC therapy(ies)\n* ECOG performance status 0-1\n* life expectancy \\> 12 weeks\n* adequate bone marrow, hepatic and renal function\n* baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval \\> 460 msec\n* Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection\u002Fdisease\n* last dose of previous anticancer therapy (including investigational agents) ≥ 28 days, radiotherapy ≥ 14 days (targeted palliative radiotherapy is allowed for lesions not planned for injections), or surgical intervention ≥ 21 days prior to the start of treatment\n* resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1 (as per NCI CTCAE Version 5.0)\n* willing to provide pre- and post-treatment tumor biopsy samples if medically feasible\n* participant is capable of understanding and complying with protocol requirements\n\nExclusion Criteria:\n\n* injectable tumors impinging upon major airways or blood vessels\n* prior treatment with recombinant interleukin-12 (IL-12)\n* have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment\n* have received live vaccines within 28 days prior to the start of ANK-101 treatment\n* have primary or acquired immunodeficient states (e.g., leukemia, lymphoma)\n* a woman of childbearing potential (WOCBP) who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment or female participant who is breastfeeding\n* prior organ transplantation\n* known history of hepatitis B virus, known active hepatitis C virus, or a positive serological test at screening within 28 days prior to the start of treatment\n* HIV-infected participants with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease\n* active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 28 days prior to the start of treatment\n* known active central nervous system (CNS) metastases\n* congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias\n* uncontrolled bleeding disorders within 4 weeks prior to the start of treatment or known bleeding diathesis - Note: Part 2 only: Participants with active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* history of hypersensitivity to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20\n* other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and\u002For interpretation of the current study\n* any acute or chronic psychiatric problems or substance abuse disorder that, in the opinion of the Investigator, make the participant unsuitable for participation\n* Part 3 only: prior Grade 3 or greater immune-mediated adverse events (imAEs) following treatment with an agent that blocks the programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) pathway.\n* Part 3 only: hypersensitivity to cemiplimab or any of its excipients or contraindications to cemiplimab per approved local labeling",{"count":215,"type":20},97,[23],"This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.",[106,219,220,221,77,107,222,80,27],"Cutaneous Tumor","Subcutaneous Tumor","Malignant Solid Tumor","Metastasis to Soft Tissue",[224,225,226,227,228,229,230],"intratumoral","intratumoral injection","solid tumors","superficial tumors","nodal tumors","subcutaneous tumors","visceral tumors","2026-03-04",{"date":233,"type":34},"2026-03-06",{"date":235,"type":34},"2024-01-19",{"date":237,"type":20},"2027-06",{"name":239,"class":92},"Ankyra Therapeutics, Inc",5,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":93},"100625734","phase-4-cosibelimab-for-cscc-in-patients-with-kidney-transplant-or-hematologic-malignancy-100625734","NCT07426484","Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy","A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)","Inclusion Criteria:\n\n* COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.)\n* COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM).\n* Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to:\n\n  * Chronic lymphocytic leukemia (CLL)\n  * Small cell lymphocytic lymphoma (SLL)\n  * Follicular lymphoma (FL)\n  * Lymphoplasmacytic lymphoma\n  * Waldenström macroglobulinemia\n  * Marginal zone lymphoma\n  * Mantle cell lymphoma, indolent variety\n  * Cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome)\n* Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to:\n\n  * Chronic myelogenous leukemia (CML)\n  * Polycythemia vera (PV)\n  * Primary myelofibrosis\n  * Essential thrombocythemia (ET)\n  * Chronic neutrophilic leukemia\n  * Chronic eosinophilic leukemia\n* Examples of myeloma, including but not limited to:\n\n  * Multiple myeloma (MM)\n  * Smoldering myeloma\n* Participants must have histologically or cytologically confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC).\n* Note: Mixed histology is acceptable (e.g. basosquamous, squamous cell carcinoma with adnexal differentiation), and other histologic variants (sarcomatoid carcinoma, spindle cell carcinoma, poorly differentiated carcinoma with squamous features).\n* Participant must have CSCC that is not amenable to surgery or radiation therapy, or recurrent despite prior surgery or radiation therapy, including locally advanced unresectable CSCC for which local therapy (surgery and\u002For radiation therapy) is not recommended. This includes CSCC occurring in patients who are not surgical candidates due to comorbidities and patients who refuse surgery (due to concerns about morbidity, disfigurement, etc).\n* Participants must have measurable disease as per PET Response Criteria in Solid Tumors version\n* (PERCIST 1.0),46 defined as any tumor (of any size) whose SUV lean (SUL) peak is greater than 1.5 times the mean SUL in the liver + 2 times its standard deviation. Mean SUL in the liver is measured in a 3-cm diameter spherical volume of interest (VOI), which is a measurement of the SUV background.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of cosibelimab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0-2 (see Appendix A for definitions of this and Karnofsky Performance Status).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1.0 K\u002FmcL\n  * Platelets ≥30 K\u002FmcL\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL\n  * AST(SGOT) ≤ 2.5 × institutional ULN\n  * ALT(SGPT) ≤ 2.5 × institutional ULN\n  * Adequate renal function, defined as defined as estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\n  * Serum creatinine ≤ 3.0 x institutional ULN or ≤ 3.0 x baseline (grade ≤ 2 per CTCAE)\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* PD-1 and PD-L1 immune checkpoint antibodies are classified as pregnancy class D. For this reason, and because other therapeutic agents used in this trial are potentially teratogenic, women of child-bearing potential (WOCBP) 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, and 120 days after completion of cosibelimab administration. 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 120 days after completion of cosibelimab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.\n* Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)\n* Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.\n* Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone \\>10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).\n* Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.\n* Participants who are receiving any other investigational agents for cancer within 2 weeks of study enrollment.\n* Participants who have uncontrolled, symptomatic infections, or infections requiring systemic antibiotics (prophylactic antimicrobials are permitted).\n* Participants who have uncontrolled or unstable brain metastases (or other CNS metastases) for whom systemic steroids are required. These patients are excluded because steroids may interfere with the effectiveness of immune checkpoint therapy.\n* Uncontrolled or significant cardiovascular disease.\n* Current need for dialysis (hemodialysis or peritoneal dialysis).\n* History of stem cell transplant or bone marrow transplant\n* Psychiatric illness or social situation that would preclude study compliance.\n* Pregnant and breastfeeding women are excluded from this study because cosibelimab is classified as pregnancy class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cosibelimab, breastfeeding should be discontinued if the mother is treated with cosibelimab.\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study drug are excluded.\n* COHORT A ONLY:\n\n  * History of organ transplant other than kidney, including a heart, lung, or liver transplant, etc, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.\n  * History of severe allergic reaction attributed to sirolimus or everolimus, or other absolute contraindication to mTOR inhibitor, as determined by the treating physician.\n* COHORT B ONLY: History of any solid organ transplant, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.",{"count":249,"type":20},80,[251],"PHASE4","This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC).\n\nThe name of the drug involved in this research study is:\n\n-cosibelimab (a type of an anti-PD-L1 antibody)",[27,29],[255,27,29,256,257,258,259,260,261,262],"Advanced Cutaneous Squamous Cell Carcinoma","Kidney Transplant Recipient","Chronic lymphocytic leukemia (CLL)","Myeloma","Waldenstrom macroglobulinemia","Solid Organ Transplant Recipient","Immunosuppressed","Lymphoma","2026-02-20",{"date":265,"type":34},"2026-02-23",{"date":267,"type":20},"2026-07",{"date":269,"type":20},"2032-12-15",{"name":271,"class":41},"Dana-Farber Cancer Institute",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"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":280,"type":20},14,[53],"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)",[27,26,284,29],"Metastatic Cutaneous Squamous Cell Carcinoma",[27,26,284,29],"2026-02-11",{"date":288,"type":34},"2026-02-13",{"date":290,"type":34},"2026-02-10",{"date":292,"type":20},"2029-06-29",{"name":294,"class":41},"Karam Khaddour, MD, MS",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":42},"100623898","ex-vivo-cutaneous-scc-100623898","NCT07402616","Ex Vivo Cutaneous SCC","Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adults with primary cutaneous squamous cell carcinoma.\n\nExclusion Criteria:\n\n* Carcinomas located on the eyelids, vulva, penis, or perianal.\n* Tumors with an anticipated excision larger than 60mm.",{"count":303,"type":20},30,[305],"NA","This is a prospective study including patients ( ≥ 18 years) referred for surgical treatment of primary cutaneous squamous cell carcinoma at the Department of Plastic Surgery, Rigshospitalet. After written and informed consent, patients will undergo standard surgical excision, followed by ex vivo 3D ultrasonography of the specimen using a 3Sonic device connected to a high-frequency ultrasound machine. This will create 3D ultrasound tomographic scans which will be interpreted by one investigator blinded to histopathology. The investigated outcomes will primarily be the deep margin distance. This will be compared to histopathology, where a pathologist - blinded to the ultrasonography results - will slice the entire specimen parallel to the ultrasound images. A third investigator will then match the histopathology images to the ultrasound images for correlation of the measured deep margins.",[27],[133,309,310,311],"3D ultrasound","ultrasonography","ex vivo","2026-02-04",{"date":286,"type":34},{"date":315,"type":34},"2026-02-01",{"date":317,"type":20},"2027-09-01",{"name":319,"class":41},"Rigshospitalet, Denmark",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":93},"100566743","thermotherapy-in-addition-to-soc-palliative-radiotherapy-100566743","NCT06659146","Thermotherapy in Addition to SOC Palliative Radiotherapy","Prospective Study to Assess the Real-world Implementation of Thermotherapy Using wIRA (Water-filtered Infrared A Superficial Hyperthermia) in Addition to Standard of Care (SOC) Palliative Radiotherapy (RT)","ThermoRad wIRA","Inclusion Criteria:\n\n1. Patient with histologically confirmed incurable or inoperable cancers with disease \\[at least one superficial lesion(s) or lymph node(s)\\] suitable for hydrosun® TWH1500 treatment\n2. Patient undergoing standard of care palliative radiotherapy (suitable with the pre-specified dose and fractionation in the protocol\n3. Aged ≥18 years old\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n5. Patient with capacity to consent\n\nExclusion Criteria:\n\n1. No superficial tumour lesion or lymph node that is suitable for hydrosun® TWH1500 treatment.\n2. Patients are not suitable for one of the pre-specified palliative radiotherapy dose and fractionation\n3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.",{"count":185,"type":20},[305],"This study aims to investigate the efficacy and safety profile of superficial hyperthermia (wIRA) in addition to standard of care (SOC) palliative radiotherapy in patients with inoperable\u002Fincurable locally advanced or recurrent\u002Fmetastatic HNSCC or cutaneous SCC superficial tumours not suitable for radical treatment.\n\nThe investigators will assess the best objective response rate (ORR) of patients with Inoperable\u002Fincurable or recurrent\u002Fmetastatic HNSCC or cSCC with superficial lesion(s) treated with the combination of superficial hyperthermia (wIRA) and palliative radiotherapy.",[108,27,332],"Breast Cancer Recurrent","2025-12-15",{"date":335,"type":34},"2025-12-22",{"date":337,"type":34},"2024-10-14",{"date":339,"type":20},"2028-03-01",{"name":341,"class":41},"King's College London",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":42},"100538235","phase-2-neoadjuvant-nivolumab-and-relatlimab-in-cutaneous-squamous-cell-carcinoma-100538235","NCT06288191","Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma","A Phase 2, Open Label, Single Arm, Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage II To IV (M0) Resectable Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Written informed consent\n3. Histologically confirmed, resectable stage II to IV cutaneous squamous cell carcinoma defined as:\n\n   Non-head and neck cuSCC:\n   1. stage II (T2, N0, M0)\n   2. stage III (T3, N0, M0; or T1-3, N1, M0)\n   3. stage IV (T1-3, N2 or N3, M0; or T4a or T4b, any N, M0)\n\n   Cutaneous head and neck CC:\n   1. stage II (T2, N0, M0)\n   2. stage III (T3, N0, M0)\n   3. stage IV (T4a or T4b, any N, M0)\n4. In-transit metastases (ITM) are permitted if they are completely resectable. ITM defined as skin or subcutaneous metastases that are \\> 20 mm from the primary lesion but not beyond the regional nodal basin.\n5. Measurable disease according to RECIST version 1.1 criteria (≥10 mm longest diameter for primary lesions and \u002F or ≥10 mm in shortest diameter for lymph nodes as determined by CT imaging) within 2 weeks of the start of study treatment.\n6. Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal cuSCC lesion (if applicable) or tissue taken for current diagnosis will also be collected.\n7. Previous radiotherapy permitted if performed at a prior site of disease not seen at baseline.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n9. Documented adequate haematological, hepatic, renal, and thyroid function determined by blood pathology\n10. Anticipated life expectancy of \\> 12 months\n11. Women of childbearing potential must have a negative serum pregnancy test within 24 hours of the first dose of study treatment or within 72 hours if this is not feasible. Effective contraception should be used for the duration of study treatment and for 5 half-lives (or 5 months) after the last dose. Egg donation (ova, oocytes) should be avoided for the same period. There are no partner-pregnancy or sperm donation avoidance requirements for male patients.\n\nExclusion Criteria:\n\n1. Clinical or radiographic evidence of distant metastasis\n2. SCC of the eyelid, vulva, penis and perianus\n3. Any contraindication to the administration of nivolumab and \u002F or relatlimab\n4. Prior anti-PD-1, CTLA-4 (Cytotoxic T-lymphocyte associated protein 4), PDL-1 (Programmed death-ligand 1) or LAG 3 (Lymphocyte-Activation Gene 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\n5. Active autoimmune disease or a requirement for chronic steroid therapy other than hormone replacement therapy\n\n   The following are permitted:\n   * Vitiligo\n   * Type I diabetes mellitus on stable insulin therapy\n   * Residual autoimmune hypothyroidism on stable hormone replacement\n   * Resolved childhood asthma or atopy\n   * Psoriasis not requiring systemic treatment\n   * Autoimmune conditions which are not expected to recur in the absence of an external trigger.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment.\n\n   The following are permitted:\n   * Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)\n   * Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n   * Non-absorbed intra-articular steroid injections.\n7. Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured.\n\n   The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n   * Basal cell carcinoma of the skin\n   * Squamous cell carcinoma of the skin\n   * Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy\n   * Prostatic intraepithelial neoplasia\n   * In situ melanoma\n   * Atypical melanocytic hyperplasia\n   * Multiple primary melanomas\n   * Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy.\n8. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:\n\n   * Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack within the 6 months prior to consent\n   * Uncontrolled angina within the 3 months prior to consent\n   * Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n   * QTc (corrected QT interval) prolongation \\> 480 ms\n   * History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc)\n   * Cardiovascular disease-related requirement for daily supplemental oxygen\n   * History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)\n   * Patients with history of myocarditis, regardless of aetiology.\n9. Troponin T (TnT) or I (TnI) \\>2 × institutional ULN (upper limit of normal). Participants with TnT or TnI levels between \\>1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤1 ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. Notification of the decision to enrol the participant following cardiologist recommendation must be made to the Lead Investigator.\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. Has had an allogenic tissue\u002Fsolid organ transplant\n13. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Pregnant or breast-feeding females\n16. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule.",{"count":350,"type":20},20,[53],"The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.",[27],[355,356,357],"neoadjuvant","immunotherapy","pathological response","2025-12-08",{"date":360,"type":34},"2025-12-16",{"date":362,"type":34},"2024-06-21",{"date":364,"type":20},"2036-07",{"name":366,"class":41},"Melanoma Institute Australia",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":391,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"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":375,"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.",[27,379,380,381,382,81,26,383,384,385,108,386,387,388,389,78,79,390,77],"SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[27,379,380,381,81,26,383,384,385,108,386,387,388,389,78,79,390,392,393,394,77],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","2025-12-02",{"date":397,"type":34},"2025-12-03",{"date":399,"type":34},"2023-05-04",{"date":401,"type":20},"2028-05-04",{"name":393,"class":41},7,{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":165,"phases":4,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":435},"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":413,"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.",[81,27,380,26,77],[192,417,418,419,420,421,422,423,424,425,426],"Predictive","Immunotherapy","Multi-omic","Tumour mutation burden","Gene expression","Tissue imaging","Machine learning","Multiplex immunofluorescence","Immune checkpoint inhibitors","Quantitative pathology","2025-09-12",{"date":429,"type":34},"2025-09-18",{"date":431,"type":34},"2021-06-08",{"date":433,"type":20},"2037-06-01",{"name":366,"class":41},3,{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":21,"phases":445,"briefSummary":446,"conditions":447,"keywords":457,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":350},"100395472","phase-1-study-of-safety-and-tolerability-of-bca101-monotherapy-and-in-combination-therapy-in-patients-with-egfr-driven-advanced-solid-tumors-100395472","NCT04429542","Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors","First-in-Human, Phase 1\u002F1b, Open-label, Multicenter Study of Bifunctional EGFR\u002FTGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors","Inclusion Criteria:\n\n* Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness).\n* Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Patients must have evaluable or measurable disease (computed tomography \\[CT\\]\u002Fmagnetic resonance imaging \\[MRI\\] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).\n* Tumor eligibility:\n\nPART B (Cohort expansion):\n\n1. Single agent BCA101 - patients with the following tumor type will be eligible:\n\n   • Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.\n\n   ii. No prior history of treatment with anti-EGFR antibodies in the unresectable\u002Fmetastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).\n2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:\n\n   • Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).\n\n   i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed \\>6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (\\>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).\n\n   ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.\n\n   iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer\n   * Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced\u002Funresectable or metastatic.\n\n     i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and\u002For metastatic disease. No prior history of immune checkpoint inhibitors.\n   * Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.\n\n   ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.\n\n   iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.\n\n   • Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.\n3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.\n\nExclusion Criteria:\n\n* For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.\n* Prior treatment with any anti-TGFβ therapy.\n* Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.\n* Pregnant or breastfeeding women.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.\n* Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.\n* Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count \\\u003C250 cells\u002FuL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n* Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment\n* Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification",{"count":444,"type":20},292,[23],"The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.",[108,448,449,450,451,452,453,27,454,455,456],"Squamous Cell Carcinoma of Anal Canal","Colorectal Cancer","Squamous Cell Carcinoma of the Lung","EGFR Amplification","Epithelial Ovarian Cancer","Pancreas Cancer","Head and Neck Neoplasms","Carcinoma, Squamous Cell","Squamous Cell Carcinoma of Head and Neck",[458,459,460,461],"TGFβ","EGFR","pembrolizumab","ficerafusp alfa","2025-08-14",{"date":464,"type":34},"2025-08-15",{"date":466,"type":34},"2020-06-01",{"date":468,"type":20},"2027-06-01",{"name":470,"class":92},"Bicara Therapeutics",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":21,"phases":481,"briefSummary":482,"conditions":483,"keywords":513,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":550},"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":480,"type":20},115,[23,53],"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.",[106,484,485,83,486,487,488,489,490,380,491,26,456,27,492,493,494,77,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,29,510,511,512],"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)","Gastric Cancer","Cervical Cancer","Bladder Cancer","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","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","Cutaneous 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",[514,515,516,517,518,519,520,115,521,522,523,524,525,526,190,527,528,529,530,531,532,533,534,356,535,381,536,537,538,539,540],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","anti-PD-1","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":543,"type":34},"2025-07-09",{"date":545,"type":34},"2021-08-27",{"date":547,"type":20},"2026-12-30",{"name":549,"class":92},"Medicenna Therapeutics, Inc.",27,{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":21,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":42},"100447565","sentinel-lymph-node-biopsy-for-cutaneous-squamous-cell-carcinoma-of-the-head-and-neck-100447565","NCT05108090","Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Patients ≥ 18 years old at the time of informed consent\n* Ability to provide written informed consent and HIPAA authorization\n* Primary or recurrent invasive cutaneous squamous cell carcinoma of the head or neck, clinically staged T2-T4 based on AJCC staging\n* Clinically and radiographically regional node-negative (no evidence of regional lymph node metastasis or distant metastasis)\n* Able to undergo general anesthesia for sentinel lymph node biopsy\n* Able to undergo CT scan with contrast or MRI with contrast\n* Undergo surgical resection (Moh's or micrographic resection or standard excision with sentinel lymph node biopsy) within 8 weeks of imaging\n\nExclusion Criteria:\n\n* Clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases\n* Known biopsy proven synchronous primary cutaneous squamous cell carcinoma\n* Pregnant patients\n* Patients unable to undergo general anesthesia\n* Patient unable to receive contrasted imaging studies\n* Patient unable to receive and\u002For allergic to 99m-Technetium sulfur colloid",{"count":558,"type":20},94,[305],"The purpose of this study is to research if a type of biopsy known as sentinel lymph node biopsy (SLNB) can help in determining the rate of tumor deposits that are hard to detect and identify in node-negative cutaneous squamous cell carcinoma of the head or neck.",[113,562,27],"Nonmelanoma Skin Cancer",[564],"sentinel lymph node biopsy","2025-06-06",{"date":567,"type":34},"2025-06-11",{"date":569,"type":34},"2021-10-25",{"date":571,"type":20},"2026-09",{"name":573,"class":41},"Indiana University",{"id":575,"slug":576,"hasResults":11,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":21,"phases":584,"briefSummary":585,"conditions":586,"keywords":590,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":240},"100579375","phase-2-towards-cure-via-only-ultra-short-icb-in-cscc-100579375","NCT06823479","Towards Cure Via Only Ultra-short ICB in CSCC","Towards Organ Preservation and Cure Via Immunotherapy in Cutaneous Squamous Cell Carcinoma Patients, Normally Undergoing Morbid Curative Surgery and Radiotherapy. The MATISSE 2 Trial, an Investigator-initiated Multicentre Phase 2 Trial","MATISSE 2","Inclusion Criteria:\n\n* 18 years of age or older\n* UV-related stage I to IVa CSCC with an indication for extensive or disfiguring surgery\n* Stage III-IVa CSCC (T3-4N0-3M0 or T0N1-3M0) or multi-focal stage I-II CSCC\n* Primary tumour site: vermillion border lip (C00.0, C00.1, C00.2), skin of lip NOS (C44.0), external ear (C44.2), skin face unspecified (ao: external lip and vestibulum nasi) (C44.3), skin scalp and neck (C44.4), overlapping lesion of skin (C44.8), primary site eyelid (C44.1), other body sites: CSCC outside head and neck area, but not vulva, anus or penis.\n* World Health Organisation (WHO) performance status of 0-2\n* Indication for SOC surgery with curative intent ± RT\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Neutrophils ≥1.5x109 \u002FL, Platelets ≥100 x109 \u002FL, Haemoglobin ≥5.5 mmol\u002FL, Creatinine ≤1.5x upper limit of normal (ULN), AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN (except patients with Gilbert Syndrome, who are eligible when total bilirubin \\\u003C 3.0 mg\u002FdL).\n* Women of child-bearing potential (WOCBP) must use appropriate method(s) of contraception. They should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required time for nivolumab to undergo five x T1\u002F2) after the last dose of the IMP.\n* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU\u002FL or equivalent units of HCG) prior to the start of ICB.\n* Patients willing and able to understand the Dutch study information and protocol requirements and comply with the treatment\u002Fintervention schedule, scheduled visits, and other requirements of the study.\n\nExclusion Criteria:\n\n* Distantly metastasized (stadium IVb) CSCC\n* SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip)\n* Patients for whom standard of care treatment consists of definitive (brachy)radiotherapy\n* Primary or recurrent CSCC appearing in an area that has been previously irradiated\n* Prior systemic therapy or immunotherapy.\n* Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C antibody (HCV Ab)\n* Subjects with any active autoimmune disease or a documented history of autoimmune disease, except: subjects with vitiligo, resolved childhood asthma\u002Fatopy, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, any condition not expected to recur in the absence of an external trigger.\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity or AEs\n* Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids (up to 5 mg of prednisone per day is allowed)\n* Patients who are pregnant or breastfeeding\n* History of allergy to study drug components and\u002For history of severe hypersensitivity to any monoclonal antibody\n* Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion.",{"count":583,"type":20},41,[53],"The goal of this clinical trial is to determine whether cutaneous squamous cell carcinoma patients can be cured using only immunotherapy, without surgery or radiotherapy.",[587,588,589,27],"Cutaneous Squamous Cell Carcinoma (CSCC)","Cutaneous Squamous Cell Cancer","Cutaneous Squamous Cell Carcinoma of the Head and Neck",[591,592,593,594,356,595,596,355],"nivolumab","opdivo","ipilimumab","yervoy","intravenous","checkpoint inhibitors","2025-05-22",{"date":599,"type":34},"2025-05-29",{"date":601,"type":34},"2025-05-14",{"date":603,"type":20},"2029-02",{"name":605,"class":41},"The Netherlands Cancer Institute",{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":612,"targetDuration":614,"studyType":165,"phases":4,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":42},"100496195","outcome-research-of-a-european-registry-platform-on-real-world-treatment-data-of-patients-with-advanced-nmsc-100496195","NCT05741073","Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC","Inclusion Criteria:\n\n1. Patients aged ≥18 years at index date\n2. Patients documented in the European NMSC-registry fulfilling EMR quality standard\n3. Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery\u002Fradiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery\u002Fradiation in routine clinical practice (Cohort 3)\n\nExclusion Criteria:\n\n1\\. Patients receiving treatment within a clinical trial.",{"count":613,"type":20},1300,"5 Years","This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC\u002FBCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.",[380,27],"2025-03-10",{"date":619,"type":34},"2025-03-12",{"date":621,"type":34},"2023-06-30",{"date":623,"type":20},"2027-12",{"name":625,"class":92},"EuMelaReg gGmbH",{"id":627,"slug":628,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":21,"phases":634,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":42},"100560451","phase-2-evaluating-the-use-of-photodynamic-therapy-to-treat-facial-cutaneous-squamous-cell-carcinoma-in-situ-sccis-100560451","NCT06577311","Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)","An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid Hydrochloride Topical Gel, 10% (Ameluz ®) With RhodoLED-XL® Red Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)\"","Inclusion Criteria:\n\n* Must be an adult (18 years of age or older)\n* Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements\n* Cannot have other dermatological disease in the SCCis target area\n* Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas\n* Voluntary written consent required\n* Allow photographs of the area of skin cancer being treated on the face\n* Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Sensitive to any of the study treatment ingredients\n* Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen\n* History of recurrence if the target SCCis lesion\n* Evidence of dermatological disease or skin condition in the treatment area\n* Medical laboratory evidence of growth patterns in the target lesion biopsy specimen\n* Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.",{"count":350,"type":20},[53],"The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source.\n\nThe main questions this trial aims to answer are:\n\n* to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and;\n* seeing how many participants had no remaining affected facial skin cancer sections after treatment.\n\nParticipants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.",[27],[638,639,113,640,641,642,643],"skin cancer","facial skin cancer","Squamous Cell Carcinoma in Situ","Cutaneous Squamous Cell Carcinoma in Situ","Facial Cutaneous Squamous Cell Carcinoma in Situ","SCCis","2024-08-27",{"date":646,"type":34},"2024-08-29",{"date":648,"type":34},"2024-08-14",{"date":650,"type":20},"2025-08",{"name":652,"class":41},"The Center for Clinical and Cosmetic Research",{"id":654,"slug":655,"hasResults":11,"nctId":656,"briefTitle":657,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":659,"phases":4,"briefSummary":660,"conditions":661,"keywords":664,"overallStatus":674,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":678,"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..",[662,663,26,27],"Cutaneous Melanoma, Stage III","Cutaneous Melanoma, Stage IV",[665,525,133,666,667,668,669,418,670,671,672,673],"CM","pDNA","plasmid DNA","pAc\u002Femm55","IFx-Hu.20","Gene Therapy","Immunology","Oncology","Immuno-Oncology","AVAILABLE","2024-08-08",{"date":677,"type":34},"2024-08-12",{"name":679,"class":92},"TuHURA Biosciences, Inc.",{"id":681,"slug":682,"hasResults":11,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":165,"phases":4,"briefSummary":689,"conditions":690,"keywords":691,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":42},"100557348","b-catenin-in-cutaneous-squamous-cell-carcinoma-and-its-mimickers-100557348","NCT06536946","B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers","Expression of B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers","Inclusion Criteria:\n\n* tissue blocks with sufficient materials Cases with sufficient data\n\nExclusion Criteria:\n\n* tissue blocks with insufficient and necrotic materials. Casas with insufficient data",{"count":688,"type":20},50,"Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it",[27],[692,693,694],"B-catenin","Cutaneous squamous cell carcinoma","Immunohistochemistry","2024-08-03",{"date":697,"type":34},"2024-08-06",{"date":699,"type":34},"2024-06-01",{"date":701,"type":20},"2025-09-30",{"name":703,"class":41},"Sohag University"]