[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-of-the-head-and-neck":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,49,94,117,170,201,229,265,287,308,339,366,397,427,447,476],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100533265","phase-2-phase-ii-trial-of-neoadjuvant-chemotherapy-nac-alone-or-in-combination-with-immunotherapy-vaccine-prgn-2009-in-subjects-with-newly-diagnosed-hpv-associated-oropharyngeal-head-and-neck-cancer-100533265",false,"NCT06223568","Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node.\n* History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Individuals who smoke currently must smoke \\\u003C10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \\>10 years before study treatment initiation. Former smokers who quit \\\u003C10 years before study treatment initiation must have smoked \\\u003C10 pack years.\n* Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery.\n\n  * Individuals must have adequate organ and marrow function as defined below:\n  * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n  * Hemoglobin (Hgb) \\>= 9.0 g\u002FdL\n  * Platelet count \\>= 100 x 10\\^9\u002FL\n  * Creatinine \\\u003C= 1.2 x upper limit of normal (ULN) OR calculated creatinine clearance \\>=55 mL\u002Fmin\u002F1.73m\\^2 by Cockcroft-Gault formula\n* Total bilirubin \\\u003C= 1 x ULN, or \\\u003C= 3 x ULN in patients with known or suspected Gilbert's Syndrome\n* Alanine aminotransferase (ALT) \\\u003C= 1.5 x ULN\n* Aspartate aminotransferase (AST) \\\u003C= 1.5 x ULN\n* Individuals serologically positive for human immunodeficiency virus (HIV) must:\n\n  * be on effective anti-retroviral therapy for at least 4 weeks; and\n  * have undetectable viral load; and\n  * have the CD4 count \\>=200 cells\u002FmicroL; and\n  * have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation\n* Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for 14 months after the last dose of cisplatin\u002Fdocetaxel. Note: IOCBP is defined as any woman who has experienced menarche and has not had a hysterectomy or bilateral oophorectomy or is not postmenopausal (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \\\u003C50 years old and need follicle stimulating hormone \\[FSH\\] in the post-menopausal range).\n\nMen must agree to use a highly effective method of contraception (surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 11 months after the last dose of the study drug(s). We also will recommend men on treatment with PRGN-2009 with female partners of childbearing potential ask female partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization) during PRGN-2009 treatment and 2 months after that.\n\n* Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s).\n* Individuals must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes.\n* Individuals must be willing to undergo pre-treatment PET\u002FCT imaging study.\n* The ability of an individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Peripheral motor or sensory neuropathy \\> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.\n* Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration. Note: Participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast).\n* Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A) https:\u002F\u002Fwww.fda.gov\u002FDrugs\u002FDevelopmentApprovalProcess\u002FDevelopmentResources\u002FDrugInteractionsLabeling\u002Fucm093664.htm#table2-2,table3-3,table5-2 within 2 weeks prior to the first study drug administration.\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.\n* Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \\\u003C= the equivalent of prednisone 10 mg\u002Fday) or other immunosuppressors such as azathioprine or cyclosporin A within 1 week prior to study treatment initiation. Note: Glucocorticoids as premedication for contrast-enhanced studies are allowed.\n* Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and\u002For does not require an additional standard of care treatment, such as, but not limited to, cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer or differentiated thyroid cancer.\n* Prior allogenic tissue\u002Fsolid organ transplant.\n* History of heart failure.\n* Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that would potentially increase risk for the participant.","ALL","18 Years","120 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nThroat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation.\n\nObjective:\n\nTo test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers.\n\nEligibility:\n\nPeople aged 18 years and older with newly diagnosed throat cancer associated with HPV.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken.\n\nAll participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles.\n\nHalf of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle.\n\nParticipants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.\n\n...",[26,27,28,29,30],"Squamous Cell Carcinoma of the Head and Neck","Oropharynx","Human Papillomavirus Viruses","Drug Therapy","Cancer Vaccine",[32,33,34,35],"Neoadjuvant Chemotherapy","Oropharynx Cancer","Human Papillomavirus","Therapeutic Vaccine","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-10","ACTUAL",{"date":42,"type":40},"2024-06-10",{"date":44,"type":20},"2028-01-10",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100455301","phase-1-a-study-of-pf-08046054sgn-pdl1v-in-advanced-solid-tumors-100455301","NCT05208762","A Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","A Phase 1 Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","Inclusion Criteria:\n\n* Parts A and B:\n\n  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)\n    * Esophageal squamous cell carcinoma (SCC)\n    * Triple negative breast cancer (TNBC)\n  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option\n  * Participants must have PD-L1 expression based on historical testing\n* Part C:\n\n  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types\n\n    * HNSCC\n\n      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC\n    * NSCLC\n\n      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.\n    * Esophageal SCC\n    * Pancreatic cancer\n    * Hepatocellular carcinoma\n    * TNBC\n    * Gastric cancer\n    * Endometrial cancer\n  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \\\u003C1 by CPS or TPS based on historical testing\n* Part D and Part E:\n\n  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC\n  * Participants must have PD-L1 expression based on historical testing\n  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS\n  * Participants with HNSCC; PD--L1 expression ≥1 by CPS\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Measurable disease per RECIST v1.1 at baseline\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.\n* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:\n\n  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * Have no new or enlarging brain metastases\n  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment\n* Lepto-meningeal disease\n* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.\n* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.\n* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nThere are additional inclusion criteria. The study center will determine if criteria for participations are met.",{"count":57,"type":20},714,[59],"PHASE1","This study will test the safety of a drug called PF-08046054\u002FSGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have five parts. Parts A and B of the study will find out how much PF-08046054\u002FSGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054\u002FSGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054\u002FSGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.",[62,26,63,64,65,66,67,68],"Carcinoma, Non-Small-Cell Lung","Esophageal Squamous Cell Carcinoma","Triple Negative Breast Neoplasms","Gastric Cancer","Endometrial Cancer","Pancreatic Adenocarcinoma","Hepatocellular Carcinoma",[70,71,72,73,74,75,76,77,78,79,80,81,82],"Non-small cell lung cancer","NSCLC","Head and neck squamous cell carcinoma","HNSCC","Triple Negative Breast Cancer","TNBC","Gastric cancer","Seattle Genetics","HCC","PDAC","Esophageal","Pfizer","Endometrial","2026-04-17",{"date":85,"type":40},"2026-04-20",{"date":87,"type":40},"2022-10-25",{"date":89,"type":20},"2029-01-04",{"name":91,"class":92},"Seagen, a wholly owned subsidiary of Pfizer","INDUSTRY",61,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100628717","phase-2-neoadjuvant-ficerafusp-alfa-with-pembrolizumab-in-resectable-scc-100628717","NCT07465276","Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC","Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.\n* Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.\n* Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T1-2, N1-3: III\n  * T3, any N: III, IVA, IVB\n  * T4, any N: IVA, IVB\n* Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).\n* Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses. Specifically, willingness to provide a newly obtained core or excisional biopsy of a tumor lesion from the primary tumor site.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1500\u002FmcL\n  * platelets ≥100 x 109\u002FL\n  * total serum bilirubin ≤1.5X upper limit of normal (ULN) (except for subjects with documented Gilbert syndrome) and AST (SGOT) and ALT (SGPT) ≤2.5X ULN\n  * AST(SGOT) \u002F ALT (SGPT) ≤3X ULN\n  * Creatinine ≤institutional ULN or GFR of ≥30 mL\u002Fmin\u002F1.73 m2\n  * Coagulation PT\u002FINR or activated partial thromboplastin time (aPTT) ≤1.5X ULN unless subject is receiving anticoagulant therapy\n* Female participants of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.\n* Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of study drugs.\n* Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until day 60 after the last dose of study drugs.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Recurrent or metastatic (M1 or IVC disease by AJCC 2017 8th edition staging) HNSCC or very early-stage HNSCC (stage I or II by AJCC 2017 8th edition staging); or head and neck cancer arising at other primary subsites such as the skin, paranasal sinuses, nasal cavity, or salivary glands.\n* HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and\u002For confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results).\n* Inoperable or surgically unresectable at baseline per the treating investigator(s).\n* ECOG performance status of 2 or greater.\n* Prior exposure to anti-EGFR antibody or anti-PD-1 immunotherapy.\n* Significant bleeding risk peri-operatively at the judgment of the treating investigator(s); such as those with a known bleeding diathesis or experiencing a major bleeding episode within 4 weeks of enrolling to the study.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* Known psychiatric, behavioral, or substance abuse disorders that would interfere with cooperation of the study requirements.\n* Subjects with chronic hepatitis B virus (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. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.\n* Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening. Note: subjects must have completed curative antiviral therapy at least 4 weeks prior to treatment.\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies). HIV testing is not required unless mandated by local health authority.\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to registration with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤6 and prostatic-specific antigen \\\u003C10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable. Other exceptions may be considered with the input of the Sponsor-Investigator.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor-Investigator.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.\n* Active pregnancy or breastfeeding.\n* Unwilling to provide tumor or blood samples for research.",{"count":102,"type":20},32,[23],"This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).\n\nThe names of the study drugs used in this research study are:\n\n* ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)\n* pembrolizumab (a type of monoclonal antibody)",[106,26],"Head and Neck Squamous Cell Carcinoma (HNSCC)","2026-03-26",{"date":109,"type":40},"2026-03-27",{"date":107,"type":40},{"date":112,"type":20},"2030-04-30",{"name":114,"class":115},"Dana-Farber Cancer Institute","OTHER",2,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":140,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":48},"100572677","phase-1-intratumoral-delivery-of-viral-replicon-sarna-particles-expressing-il-12-in-head-and-neck-cancer-100572677","NCT06736379","Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer","Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer","Inclusion Criteria:\n\n1. Cohort A - Unresectable or recurrent\u002Fmetastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:\n\n   Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.\n\n   Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n\n   Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).\n\n   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).\n\n   Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.\n\n   OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.\n3. Primary tumors should be amenable to intratumoral (IT) injection \\>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.\n4. Subjects with either a local recurrence or a new primary tumor will be allowed.\n5. Age ≥ 18 years.\n6. Have acceptable organ and marrow function defined as follows:\n\n   Absolute neutrophil count ≥ 1,500\u002FmcL Platelets ≥ 100,000\u002FmcL Hemoglobin ≥ 8.0 g\u002FdL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN\n7. Ability to understand and the willingness to provide written informed consent.\n8. Life expectancy \\> 12 weeks (about 3 months).\n9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.\n2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.\n3. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.\n4. Participation in another clinical study with an investigational product during the last 30 days.\n5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.\n6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n7. If applicable: Women who are breastfeeding.\n8. History of allogenic organ transplant that requires use of immunosuppressives.\n9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.\n10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.\n12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.",{"count":125,"type":20},41,[59],"The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:\n\nThe safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)\n\nThe tumor response to IT injections of VLPONC-01\n\nThe tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment\n\nResearchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.",[129,130,131,73,132,133,134,135,26,136,137,138,139],"Head and Neck Cancers- Squamous Cell","Head and Neck Cancer","Solid Tumors","SCC - Squamous Cell Carcinoma","SCCHN","Head Neck Cancer","Head and Neck Squamous Cell Cancer","Squamous Cell Carcinoma, Head And Neck","Squamous Cell Head and Neck Carcinoma","Oral Cavity","Oral Cavity Carcinoma",[141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160],"Virus-like particle","VLP","IL-12","Interleukin 12","Intratumoral","VRP","Viral Replicon Particle","saRNA","VRP-encapsulated","IT injection","pembrolizumab","anti-PD-1","tumor resection surgery","tumor resection","Self-amplifying RNA","Multiple inoculations directly into the tumor","Keytruda","viral particles per injection","viral particles","macrophage","2026-01-15",{"date":163,"type":40},"2026-01-20",{"date":165,"type":40},"2025-05-13",{"date":167,"type":20},"2027-12-30",{"name":169,"class":92},"VLP Therapeutics",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100617597","phase-3-de-escalation-surgery-after-immunotherapy-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100617597","NCT07320690","De-Escalation Surgery After Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Randomized Controlled Clinical Study of De-Escalation Surgery Following Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma","Neo-Margin","Inclusion Criteria:\n\n1. Age between 18 and 75 years inclusive, with no restriction on gender.\n2. Histologically confirmed primary squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma).\n3. Clinical stage III-IVa according to the AJCC 8th edition TNM staging system prior to immunotherapy; specifically, stage III-IVa for oropharyngeal squamous cell carcinoma (p16-negative) or stage III for oropharyngeal squamous cell carcinoma (p16-positive).\n4. ECOG performance status of 0 or 1.\n5. Life expectancy of ≥6 months.\n6. Received preoperative immune checkpoint inhibitor therapy, primarily with anti-PD-1 monoclonal antibodies or bispecific antibodies containing an anti-PD-1 arm, regardless of brand, with or without concurrent chemotherapy or targeted therapy, for no more than six cycles.\n7. Achieved complete response (CR) or partial response (PR) on imaging assessment after preoperative therapy, according to RECIST 1.1 criteria.\n8. Assessed as eligible for de-escalation surgery based on clinical evaluation by the surgeon. Examples include omission of surgery on the primary lesion; preservation of critical structures or functions, such as retaining the mandible initially planned for resection; avoidance of flap reconstruction; or limitation of tongue resection to less than half when hemi-glossectomy was initially indicated.\n9. No prior curative surgery or radiotherapy for the current tumor.\n10. Willing to undergo surgical treatment.\n11. No significant contraindications to surgery.\n12. Voluntary participation in the study, signed informed consent, good compliance, and willingness to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Severe underlying diseases making the patient unable to tolerate surgery.\n2. Current tumor is recurrent.\n3. Myocardial infarction, severe\u002Funstable angina, NYHA class II or higher heart failure, or symptomatic congestive heart failure within 6 months before randomization.\n4. History of psychiatric drug abuse or drug addiction.\n5. Pregnant or breastfeeding women.\n6. Diagnosis of other malignancies within 5 years prior to study entry, except for locally treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n7. Any other severe physical or mental illness, or laboratory abnormalities that might increase the risk associated with participation or interfere with the study results, or any other conditions deemed unsuitable for participation by the investigator.","75 Years",{"count":180,"type":20},356,[182],"PHASE3","This is a multicenter, randomized, open-label, non-inferiority clinical trial designed to evaluate whether downgraded surgery-guided by post-immunotherapy tumor boundaries-can achieve comparable 3-year overall survival (OS) to standard surgery in patients with Stage III-IVa locally advanced head and neck squamous cell carcinoma (HNSCC) who have responded to neoadjuvant immunotherapy. A total of 356 patients will be randomized 1:1 to receive either downgraded or standard surgery, followed by risk-adapted adjuvant therapy. The primary endpoint is 3-year OS, with secondary endpoints including disease-free survival, quality of life, complication rates, and cost-effectiveness. The study hypothesizes that downgraded surgery will preserve organ function and quality of life without compromising survival outcomes.",[26],[186,187,188,189,190],"Head and Neck Squamous Cell Carcinoma","Locally advanced","De-escalation surgery","Standard surgery","Immunotherapy","NOT_YET_RECRUITING","2025-12-27",{"date":194,"type":40},"2026-01-06",{"date":196,"type":20},"2026-01-01",{"date":198,"type":20},"2031-07-01",{"name":200,"class":115},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":5},"100464579","phase-1-modi-1-moditope-in-breast-head-and-neck-ovarian-or-renal-cancer-100464579","NCT05329532","Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer","A Phase 1\u002F2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer","ModiFY","INCLUSION CRITERIA\n\n1. Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:\n\n   * TNBC\n   * SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)\n   * HGSOC including fallopian tube and primary peritoneal cancers\n   * RCC Or the patient has histologically or cytologically confirmed SCCHN scheduled to have curative intent surgical resection.\n2. Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:\n\n   * TNBC:\n\n     * patient has received available standard therapy for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a systemic treatment regimen with immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     * patient has received first-line platinum-containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient with locally advanced or metastatic disease measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient completing immunotherapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient with untreated metastatic or unresectable recurrent SCCHN whose tumours express PD-L1 with a combined positive score (CPS) of one or more and are eligible for SOC immunotherapy (Modi-1ev\u002FModi-1eKv + CPI cohort only). Patients who received their first dose of CPI therapy within 28 days of the first dose of Modi-1ev\u002FModi-1eKv are eligible.\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     o neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom minimum of 3 weeks of Modi-1ev\u002FModi-1eKv and a single 400 mg intravenous (i.v.) total dose of pembrolizumab immunotherapy can be administered. Patients will only be enrolled once the Modi-1 Moditope® expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) have been established.\n   * HGSOC including fallopian tube and primary peritoneal cancers:\n\n     * patient must be considered unsuitable for platinum chemotherapy, defined as recurrence\u002Fprogression within 6 months of prior platinum-containing chemotherapy or patients in whom platinum therapy is no longer thought appropriate. Patient must have received no more than two non-platinum regimens, from the time the patient is considered unsuitable for platinum chemotherapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a course of systemic therapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * RCC:\n\n     * patient is untreated for advanced RCC (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has received first-line treatment consisting of anti-angiogenic therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has intermediate or poor International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) and is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient on active surveillance (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n3. Where applicable, patient has completed last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.\n4. Patient has been fully vaccinated against COVID-19, the last vaccination being at least 14 days prior to the patient's first dose of IMP, except for those who have declined or are not eligible for COVID-19 vaccination.\n5. Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.\n6. Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI) (non-neoadjuvant cohorts).\n7. Wherever possible, patients not scheduled for curative intent resection surgery should have a fresh tumour biopsy (or have an archival biopsy \\[obtained within the past 5 years\\] if obtaining a fresh biopsy is not feasible) at baseline for molecular studies, and agree to a post-treatment biopsy (at Week 25 or one of the EOT visits), if feasible. Patients in the SCCHN neoadjuvant cohort must have both a fresh pre-treatment biopsy and agree to have their resected tumour analysed.\n8. Patient is male or female and at least 18 years of age.\n9. Patient has a life expectancy of more than 6 months.\n10. Patient has an ECOG performance status of 0 or 1.\n11. Patient has adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 109\u002FL, platelets ≥100 x 109\u002FL, haemoglobin \\>90 g\u002FL (\\>5.6 mmol\u002FL), lymphocytes ≥ 1 x 109\u002FL, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\]) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present.\n12. Patient must be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed).\n13. Women of child-bearing potential must have a negative serum pregnancy test during Screening (and a urine test within the 7 days prior to Day 1) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the Summary of Product Characteristics \\[SmPC\\] of the CPI requires it).\n14. Men who are potentially fertile with partners of child-bearing potential must agree to use highly effective contraceptive methods for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the SmPC of the CPI requires it).\n15. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n16. Patient scheduled to receive a CPI (e.g., pembrolizumab alone or nivolumab alone or where applicable with ipilimumab) together with Modi-1ev\u002FModi-1eKv must have been clinically evaluated, have not received prior CPI therapy, and the CPI must be deemed an appropriate treatment for their disease according to the CPI's SmPC (this does not apply to the neoadjuvant SCCHN cohort).\n\nEXCLUSION CRITERIA\n\n1. Patient has symptomatic central nervous system metastases or carcinomatous meningitis.\n2. Patient is taking any systemic steroid therapy (exceeding 10 mg\u002Fday of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.\n3. Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate \\>90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.\n4. Patient is pregnant, lactating, or is expecting to conceive\u002Ffather children within the duration of the study.\n5. Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.\n6. Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction or stroke within previous 6 months, a history of significant cardiac abnormality and\u002For significant abnormal baseline ECG readout, active ischaemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy, uncontrolled hypertension, significant cerebrovascular disease, or congestive heart failure.\n7. Patient has anti-CCP antibody levels classified as equivocal or positive according to NHS guidelines, i.e., ≥ the ULN, or has an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.\n8. Patient has received a live vaccine within 28 days, or an influenza vaccine within 14 days prior to the first dose of IMP. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.\n9. Patient has a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV; surface antigen reactive) or hepatitis C (HCV; RNA detected).\n10. COVID-19 vaccination within 14 days prior to the first dose of IMP.\n11. Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.\n12. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis \\[SJS\u002FTEN\\], or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\]), or dose-limiting immune-mediated reactions (Modi-1ev\u002FModi-1eKv + CPI RCC cohort only).\n13. Patient has a known hypersensitivity to the IMP under study or their excipients. Where SOC CPIs are planned to be given with the IMP, the patient must not have a known hypersensitivity to the CPIs or their excipients.",{"count":210,"type":20},168,[59,23],"The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced\u002Funresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).\n\nModi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.",[74,214,215,26],"Renal Cell Cancer","High Grade Ovarian Serous Adenocarcinoma",[217,218,219],"vaccine","peptide","Phase II","2025-09-11",{"date":222,"type":40},"2025-09-17",{"date":224,"type":40},"2022-04-07",{"date":226,"type":20},"2027-07-01",{"name":228,"class":92},"Scancell Ltd",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825","NCT05059444","ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation","ORACLE","Inclusion Criteria:\n\n* Age \\> 18 years old AND\n* Initial treatment is given with curative\u002Fradical intent AND\n* Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND\n* Provided written informed consent to participate in the study AND\n* Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND\n* Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND\n* Have at least one Landmark blood sample\n\nHave a histologically confirmed Index Cancer that qualifies for inclusion, defined as:\n\nPrimary Study Cohorts\n\n* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),\n* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):\n\nCohort 2A: Resectable OR Cohort 2B: Unresectable,\n\n* Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:\n\nCohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive\u002FHER2-negative invasive breast carcinoma,\n\n* Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,\n* Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),\n* Cohort 6: Gastric adenocarcinoma (stage II-III),\n* Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,\n* Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),\n* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),\n* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),\n* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)\n\nExploratory Cohort\n\n* Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen\n\nExclusion Criteria:\n\n* History of allogeneic organ or tissue transplant\n* Index cancer has predominantly neuroendocrine histology\n* History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral\u002Fmultifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment\n* Known distant metastasis at time of enrollment (with the exception of participants with limited\u002Fresectable stage IV cutaneous melanoma or RCC)",{"count":237,"type":20},2020,"OBSERVATIONAL","The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.",[241,242,243,244,245,246,247,248,249,67,26,250,251,252,253,254],"Bladder Carcinoma","Ureter Carcinoma","Renal Pelvis Carcinoma","Non-small Cell Lung Cancer","Invasive Breast Carcinoma","Cutaneous Melanoma","Esophageal Carcinoma","Gastroesophageal Junction Carcinoma","Gastric Adenocarcinoma","Epithelial Ovarian Carcinoma","Fallopian Tube Carcinoma","Endometrial Carcinoma","Renal Cell Carcinoma","Rectal Adenocarcinoma","2025-08-18",{"date":257,"type":40},"2025-08-22",{"date":259,"type":40},"2021-09-07",{"date":261,"type":20},"2029-08",{"name":263,"class":92},"Guardant Health, Inc.",57,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100534256","identification-of-the-pathogenetic-mechanisms-underlying-squamous-cell-carcinomas-100534256","NCT06236464","Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas","Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas of the Anogenital Tract and of the Head-neck Region for the Development of Shared Therapeutic Strategies","Inclusion Criteria:\n\nPatients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. Prospective patients must provide written informed consent before any procedures.\n\nExclusion Criteria:\n\nPatients presenting any of the following criteria are not eligible for inclusion in this study. Exclusion criteria include:\n\n1. Metastatic neoplasia\n2. Treatment for other oncological pathologies\n3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)",{"count":273,"type":20},170,"This is a multicentric, retrospective, and prospective biomarker study.",[26,276],"Squamous Cell Carcinoma of the Anus","2025-07-24",{"date":279,"type":40},"2025-07-29",{"date":281,"type":40},"2023-09-25",{"date":283,"type":20},"2026-03",{"name":285,"class":115},"National Cancer Institute, Naples",4,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":48},"100338784","phase-1-vx152503-in-combination-with-ipilimumab-or-nivolumab-in-patients-with-head-and-neck-cancer-100338784","NCT03690986","VX15\u002F2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer","Integrated Pilot Biomarker Trial of VX15\u002F2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer","Inclusion Criteria:\n\n* Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed\n* Oropharyngeal tumors must have p16 testing done\n* Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection\n* Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory\n* No prior treatment for HNSCC\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Absolute neutrophil count ≥ 1,500 cells\u002FµL\n* Platelets ≥ 100,000\u002FµL\n* Hemoglobin ≥ 9.0g\u002FdL (may receive packed red blood cell \\[prbc\\] transfusion)\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN\n* Calculated creatinine clearance of ≤ 50 mL\u002Fmin\n* International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \\\u003C 1.1 units\u002FmL (U\u002FmL) are allowed on the trial\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and willingness to sign a written informed consent document\n* Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion\n* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion\n* Female subjects of childbearing age must have a negative serum pregnancy test at study entry\n\nExclusion Criteria:\n\n* Poor venous access for study drug administration\n* Nasopharynx cancer, cancer of unknown primary, sinonasal cancer\n* Determined not to be a surgical candidate due to medical co-morbidities\n* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)\n* Prior organ allograft or allogeneic bone marrow transplantation\n* Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Women who are pregnant or lactating\n* Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Other medications, or severe acute\u002Fchronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study\n* Clinical evidence of bleeding diathesis or coagulopathy\n* Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma fully resected) unless disease free for a minimum of one year\n* Patients that have had prior treatment for HNSCC are not eligible\n* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment\n* Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab\n* No archival tissue available pre-study treatment, and repeat biopsy not feasible",{"count":295,"type":20},50,[59],"This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15\u002F2503 (VX15\u002F2503) with or without ipilimumab and\u002For nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15\u002F2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.",[26],"2025-07-18",{"date":301,"type":40},"2025-07-23",{"date":303,"type":40},"2018-11-01",{"date":305,"type":20},"2027-11-30",{"name":307,"class":115},"Emory University",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":315,"enrollmentInfo":316,"targetDuration":318,"studyType":238,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":48},"100587521","cisplatin-induced-cochlear-and-vestibular-damage-in-head-and-neck-cancer-100587521","NCT06929468","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer","Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study","Inclusion Criteria:\n\n* Diagnosis of head and neck squamous cell carcinoma\n* Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group)\n* Age 18 to 85 years\n* Signed agreement and willingness to participate in the study and adhere to the study protocol\n\nExclusion Criteria:\n\n* Severe hearing impairment (WHO grade 3 or 4, corresponding to an audiometric ISO value of ≥61 dB in the better ear at frequencies of 500, 1000, 2000 and 4000 Hz)\n* Self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study)\n* Current cochlear implant\n* Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months\n* Acute psychosis or serious psychiatric illness\n* Addiction disorder","85 Years",{"count":317,"type":20},55,"6 Months","The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.",[321,322,323,324,130,325,326,327,26,328,329],"Ototoxic Hearing Loss","Ototoxicity, Drug-Induced","Cisplatin-induced Hearing Loss","Cisplatin Ototoxicity","Dizzyness","Inner Ear Hearing Loss","Vestibular Disease","Deafness","Hearing Loss","2025-04-14",{"date":332,"type":40},"2025-04-16",{"date":334,"type":20},"2025-07",{"date":336,"type":20},"2027-06",{"name":338,"class":115},"Simon Jäger",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":48},"100583397","phase-1-safety-and-efficacy-trial-of-tv5m01-for-radiation-induced-mucositis-in-head-and-neck-cancer-patients-100583397","NCT06875791","Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.","A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer","TEMOR","Inclusion Criteria:\n\nAge ≥ 18 years and \\\u003C 60 years\n\nDiagnosis of HNSCC of the oral cavity, larynx, oro- and hypopharynx, diagnostic stage III-IV according to the AJCC 8th edition, scheduled to start radiotherapy\n\nAbility to swallow solids and liquids before starting radiotherapy treatment\n\nAdequate contraception for both sexes:\n\nFor women: negative pregnancy test for women of childbearing age; must be surgically sterile, postmenopausal (defined as absence of menstrual cycle for at least 12 consecutive months), or comply with an acceptable contraceptive regimen during and 3 months after the treatment period\n\nFor men: must be surgically sterile or comply with a contraceptive regimen during and for 3 months after the treatment period\n\nPerformance status (ECOG) of 0-1, measured within 72 hours prior to treatment initiation\n\nExpected life expectancy ≥ 6 months\n\nAdequate renal function \\[creatinine ≤ 1.5 times the upper limit of normal (ULN) or Glomerular Filtration Rate ≥ 50 ml\u002Fmin\\]\n\nAdequate liver function \\[total bilirubin ≤ 1.5 x ULN; AST or ALT ≤ 3 x ULN or ≤ 5 x ULN if due to tumor liver involvement\\]\n\nProvision of signed and dated informed consent before initiating any study-related procedure\n\nMeeting the diagnostic criteria for grade 1 or higher mucositis according to WHO classification\n\nMeeting the criteria for starting radiotherapy\n\nWilling and able to participate in the trial and comply with all trial requirements\n\nExclusion Criteria:\n\nPatients not eligible for radiotherapy\n\nStomatological disease such as ulcers, edema, exudation in the oropharyngeal mucosa before radiotherapy\n\nWomen who are pregnant or breastfeeding\n\nPatients allergic or sensitive to any of the compounds in the gel or study medications\n\nPresence of lesions that completely occlude the upper digestive tract\n\nPatients with a history of disorders, specifically those with psychotic psychiatric disorders such as schizophrenia, schizoaffective disorder, and delusional disorder, and substance\u002Falcohol abuse\n\nPatients participating or who have participated in another clinical trial in the last 30 days\n\nAnother uncontrollable, severe, hemodynamically unstable concurrent medical condition requiring urgent attention or threatening the patient's life\n\nReceiving chemotherapy regimens with delayed toxicity within the last 4 weeks (six weeks for nitrosourea or mitomycin C) or continuous or weekly chemotherapy regimen with limited potential for delayed toxicity within the last two weeks\n\nAny evidence of oral infection or disease in the oral cavity other than HNSCC\n\nAny important medical disease or incidental abnormal laboratory finding that could increase the participant's risk in the study (based on the investigator's judgment)\n\nConcomitant therapy with drugs that inhibit or enhance opioid action\n\nHypersensitivity to opioids, respiratory depression, obstructive airway disease, acute liver disease, seizure disorder, increased intracranial pressure, paralytic ileus, patients with known sensitivity to morphine, pheochromocytoma, acute asthma exacerbations, history of cardiac arrhythmia, heart failure.","60 Years",{"count":349,"type":20},40,[59,23],"This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma.\n\nThe trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution.\n\nPrimary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors.\n\nThe study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.",[26,353],"Oral Mucositis",[355,356],"Oral mucositis","Squamous cell carcinoma","2025-03-26",{"date":359,"type":40},"2025-04-01",{"date":361,"type":20},"2025-12-28",{"date":363,"type":20},"2026-12-31",{"name":365,"class":115},"Fundacion Clinica Valle del Lili",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":381,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":48},"100503480","phase-2-intratumoral-gemcitabine-paclitaxel-carboplatine-and-intravenous-nivolumab-for-locally-recurrence-of-head-and-neck-cancers-100503480","NCT05835804","Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers","NIVOCHIMLOC","Inclusion Criteria:\n\n* WHO status : 0, 1 or 2.\n* Age \\> 18ans\n* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)\n* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy\n* Possible location of the tumour by clinical examination, CT-scan\n* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.\n* Neutrophils \\> 1000\u002Fmm3.\n* Platelets \\> 100 000\u002Fmm3.\n* Blood créatinine \\\u003C 15 mg\u002FL. Blood bilirubine \\\u003C 30 mg\u002FL\n* Prothrombin rate \\> 70 %.\n* Social insurance\n* Informed consent\n\nExclusion Criteria:\n\n* WHO status : 0, 1 or 2.\n* Age \\> 18ans\n* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)\n* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy\n* Possible location of the tumour by clinical examination, CT-scan\n* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.\n* Neutrophils \\> 1000\u002Fmm3.\n* Platelets \\> 100 000\u002Fmm3.\n* Blood créatinine \\\u003C 15 mg\u002FL. Blood bilirubine \\\u003C 30 mg\u002FL\n* Prothrombin rate \\> 70 %.\n* Social insurance\n* Informed consent",{"count":374,"type":20},39,[23],"Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.\n\nIntratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.\n\nThe aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.",[26,378,379,380],"Paclitaxel","Carboplatin","Nivolumab",[26,382,383,384,385,386,387],"local reccurence of malignant tumor","intrumoral chemotherapy","gemcitabin","paclitaxel","carboplatin","nivolumab","2025-03-18",{"date":390,"type":40},"2025-03-21",{"date":392,"type":20},"2025-11",{"date":394,"type":20},"2027-04",{"name":396,"class":115},"Centre Hospitalier Universitaire, Amiens",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":21,"phases":407,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":48},"100377202","phase-2-fluorescence-guided-surgery-using-crgd-zw800-1-in-oral-cancer-100377202","NCT04191460","Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer","Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging","GuidedbyLight","Inclusion Criteria:\n\n1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;\n2. ≥ 18 years of age;\n3. Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations;\n4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.\n\nExclusion Criteria:\n\n1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;\n2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.\n3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;\n4. Patients with renal insufficiency (eGFR\\\u003C60);\n5. Patients with a previous kidney transplantation in the medical history;\n6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;\n7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.",{"count":406,"type":20},28,[23],"This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.",[26,410,411],"Oral Cancer","Squamous Cell Carcinoma of the Oral Cavity",[413,414,415,416,417],"cRGD-ZW800-1","fluorescence-guided surgery","image-guided surgery","fluorescence imaging","cancer","2025-02-25",{"date":420,"type":40},"2025-02-26",{"date":422,"type":40},"2022-07-12",{"date":424,"type":20},"2025-07-01",{"name":426,"class":115},"Erasmus Medical Center",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":48},"100253042","patient-derived-xenograft-models-of-tumor-from-patients-with-head-and-neck-cancer-100253042","NCT02572778","Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer","Establishment of Primary Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer for Preclinical Evaluation of Targeted Therapies.","UCL-Xenog","Inclusion Criteria:\n\n* In the first phase, all patients with primary or recurrent\u002F metastatic disease of head and neck cancer can be included pre-operatively or before a tumor biopsy after obtaining informed consent\n* Data on stage, grade, histology, adjuvant treatment, responses, relapse should be available\n* Follow-up data should be available\n* Patients with recurrent disease are allowed\n* Written informed consent",{"count":349,"type":20},"The investigators want to have a collection of fresh primary or recurrent tumor tissue for establishment of patients-derived xenografts in order to:\n\ngenerate a biobank of in vivo patient xenografts representing the different subgroups of tumors for head and neck cancer\n\n* perform genetic and transcriptional profiling of the primary, metastatic tumors and xenograft tumors\n* evaluate the efficacy of new targeted agents, whether or not in combination with standard treatment options\n* evaluate biomarkers of drug sensitivity\n* study primary and secondary (acquired) resistance in these models",[26],"2024-12-02",{"date":440,"type":40},"2024-12-03",{"date":442,"type":40},"2015-09",{"date":444,"type":20},"2025-12",{"name":446,"class":115},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":475},"100422915","phase-1-phase-1a-and-phase-2-study-for-safety-preliminary-efficacy-pk-and-pd-of-st-067-100422915","NCT04787042","Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067","A First-In-Human Phase 1\u002F2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Male and female patients aged ≥18 years\n2. Must provide written informed consent and any authorizations required by local law\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Have histologically or cytologically confirmed diagnosis of advanced\u002Fmetastatic solid tumor\n\n   For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer.\n   1. For patients who have developed disease progression through standard therapy, or\n   2. For patients whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the investigator and after consultation with the Medical Monitor) For Phase 1 combination therapy dose escalation, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC (with no EGFR, TRK receptor, or ALK positive mutations\u002Ffusions), TNBC, SCCHN, MSI-Hi tumors, Hi TMB or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, and HCC\n\n      * TNBC is diagnosed in a tumor which does not express estrogen receptor or progesterone receptor, is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization (FISH).\n      * MSI high tumor should have mutations in 30% or more microsatellites by PCR or be negative for MSH1\u002F2\u002F6 or PMS-2 by IHC.\n      * Hi-TMB high tumor has 10 mut\u002FMb or greater calculated from whole genome sequencing or whole exome sequencing\n\n   For Phase 2, the following solid tumors are allowed:\n\n   Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors\n5. Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation\n6. Has an accessible tumor for biopsy pre- and on-treatment (mandatory).\n\nExclusion Criteria:\n\n1. History of another malignancy\n2. Known symptomatic brain metastases requiring \\>10 mg\u002Fday of prednisolone or equivalent\n3. Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV\n4. Any degree of respiratory compromise (from either malignant or non-malignant disease)\n5. Evidence of an ongoing systemic bacterial, fungal, or viral infection\n6. Has received a live vaccine within 30 days\n7. Major surgery within 4 weeks\n8. Prior solid organ or bone marrow progenitor cell transplantation\n9. Prior high dose chemotherapy requiring stem cell rescue\n10. History of active autoimmune disorders\n11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.\n12. Treatment with an approved, systemic anticancer therapy or an investigational agent within 4 weeks of Day 1\n13. A positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral test within 28 days prior to dosing, unless there is Investigator-confirmed clinical recovery on or before C1D1\n14. Subjects with adrenal insufficiency\n15. Subjects with any chemistry or hematology laboratory values that are ≥Grade 2\n\n    Additional exclusion criteria for Phase 1 combination therapy only:\n16. Presence of known active CNS metastases and\u002For carcinomatous meningitis. Subjects 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, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n17. Prior radiotherapy within 2 weeks of start of study treatment or history of radiation pneumonitis.\n18. Presence of an active documented autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or insulin) is not considered a form of systemic treatment and is allowed. Subjects may use topical and\u002For inhaled corticosteroids. However, subjects with adrenal insufficiency on replacement doses of steroids are not allowed.\n19. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE\n20. Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients. Subjects who have been retreated after such a reaction may be allowed after discussion with the Simcha Medical Monitor\n21. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n22. Subjects that have received radiation therapy to the lung that is \\>30Gy within 6 months of the first dose of study treatment",{"count":455,"type":20},316,[59,23],"This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \\[Gazyva®\\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.",[459,460,461,253,462,463,26,464,465],"Cancer","Solid Tumor","Melanoma","Triple-negative Breast Cancer","Non Small Cell Lung Cancer","Carcinoma","MSI-High","2024-11-13",{"date":468,"type":40},"2024-11-15",{"date":470,"type":40},"2021-08-06",{"date":472,"type":20},"2025-12-31",{"name":474,"class":92},"Simcha IL-18, Inc.",6,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":485,"conditions":486,"keywords":487,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100219822","collection-of-plasma-samples-for-squamous-cell-carcinoma-of-the-head-and-neck-patients-100219822","NCT02139020","Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients","Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* patients treated with radiation therapy and cetuximab according to Bonner et al\n* patients treated with cetuximab in combination with chemotherapy according to Vermorken et al.\n* patients treated with a molecular targeted agent as a part of a clinical study\n\nExclusion Criteria:\n\n* patients with another type of head and neck cancer\n* patients non treated with targeted therapies",{"count":484,"type":20},400,"The investigators will collect plasma samples at baseline, during treatment, and at progression.",[26],[488,489],"Targeted therapies","Plasma samples","2023-12-08",{"date":492,"type":40},"2023-12-11",{"date":494,"type":4},"2013-02",{"date":496,"type":20},"2033-01",{"name":446,"class":115},5]