[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-melanoma":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,64,116,236,262,286,333,368,394,412,432,463,489],{"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":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100449723","phase-2-bicazo-a-study-combining-two-immunotherapies-cabozantinib-and-nivolumab-to-treat-patients-with-advanced-melanoma-or-squamous-cell-head-and-neck-cancer-an-immunomatch-pilot-study-100449723",false,"NCT05136196","BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study","Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study","Inclusion Criteria:\n\n* STEP 1 - SPECIMEN SUBMISSION\n* Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible\n\n  * Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration\n* Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration\n* Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable\n* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration\n* Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration\n* Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)\n* Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management\n* Participants must have recovered to baseline or =\\\u003C grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy\n* Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria:\n\n  * If the primary radiation is combined with chemotherapy, a minimum of 16 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration. If the radiation is given alone, a minimum of 8 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration\n  * Additional palliative radiotherapy regimens are permitted but cannot have been administered to previously treated tissue (i.e., overlapping fields are excluded) with the exception of central nervous system (CNS) radiation and must be completed at least 4 weeks prior to step 1 registration\n  * Treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation\n* Participants must not have received prior treatment with anti-VEGF therapies for any reason\n* Participants must be \\>= 18 years of age\n* Participants must have a Zubrod Performance Status 0 or 1\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better to be eligible for this trial\n* Participants must not have any known significant organ disfunction that, in the opinion of the treating investigator, may impact suitability for receiving combination nivolumab\u002Fcabozantinib treatment\n* Participants must be able to take oral medication without breaking, opening, crushing, dissolving or chewing capsules\n* Participants must not have malabsorption syndrome\n* Participants must not have active autoimmune disease requiring systemic steroids (equivalent of \\> 10mg of prednisone) or other immune suppression. Exceptions:\n\n  * Type 1 diabetes mellitus\n  * Endocrinopathy only requiring hormone replacement\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n  * Conditions not expected to recur in the absence of an external trigger\n* Participants must not have received an organ allograft\n* Participants must not have a history of hemoptysis (defined as \\>= 1\u002F2 tsp of bright red blood per day) or tumor bleeding within 90 days prior to step 1 registration\n* Participants must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with cabozantinib therapy:\n\n  * Prior carotid bleeding\n  * Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies\n  * Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies\n  * Any prior history of bleeding related to the current head and neck cancer\n  * History of gross hemoptysis (bright red blood of 1\u002F2 teaspoon or more per episode of coughing) within 3 months\n* Participants must not require concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)\n\n  * Participants must not require anticoagulants except for the following:\n\n    * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to step 1 registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to step 1 registration as documented by baseline blood pressure reading with systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 90 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing due to the known safety profiles of the drugs in this study. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential\". In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion and vasectomy with testing showing no sperm in the semen\n* Have an adequate archival tissue specimen verified by the local pathologist and documented on the Pathology Review Form from a procedure obtained after the development of resistance to anti-PD-1\u002FL1 therapy. Archival tissue must consist of tumor block or at least 1 hematoxylin and eosin (H\\&E)-stained 4-5 micron slide and 20 freshly cut serially sectioned and numbered 4-5 micron unstained, uncharged slides OR\n\nBe willing to undergo research biopsy AND have tumor accessible for biopsy based on the following criteria:\n\n* Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be obtained incidentally to a clinically necessary procedure and NOT for the sole purpose of the clinical trial\n* Acceptable biopsy procedures are:\n\n  * Percutaneous biopsy with local anesthetic and\u002For sedation with an expected risk of severe complications \\\u003C 2%\n  * Direct transoral biopsy (with or without local anesthetic and\u002For sedation) with an expected risk of severe complications \\\u003C 2%\n  * Excisional cutaneous biopsy with local anesthetic and\u002For sedation with an expected risk of severe complications \\\u003C 2%\n  * Biopsy with removal of additional tumor tissue during a medically necessary mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or craniotomy. No open surgical, laparoscopic or endoscopic procedure should be performed solely to obtain a biopsy for this protocol\n  * Removal of additional tumor tissue during a medically necessary surgical procedure\n\n    * Participants must submit whole blood for germline genomic analysis\n    * Participants must have been offered the opportunity to participate in specimen banking\n    * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n\n  * STEP 2 TREATMENT REGISTRATION\n* Note: No tests or exams are required to be repeated for step 2 registration (Treatment). However, participants who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration\n\n  * Participants must continue to meet eligibility for step 1 registration prior to step 2 registration\n  * Participants must have had their tumor tissue submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration\n  * Participants registered during stage II of the protocol must have received assignment to an open cohort from the SWOG Statistics and Data Management Center based on their biomarker screening profile (not applicable for patients registered during stage I of the protocol)\n  * Participants must have measurable disease. All measurable disease must be assessed within 28 days prior to step 2 registration. All non-measurable disease must be assessed within 42 days prior to step 2 registration. Note: All disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n  * For melanoma participants, CT chest, abdomen and pelvis must be obtained. For HNSCC participants, CT neck and chest must be obtained. Further imaging (i.e., MR brain, CT abdomen\u002Fpelvis or extremities, bone scan) will be performed as deemed appropriate by the treating physician\n  * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy\n  * Participants must not have experienced any significant health changes that, in the opinion of the treating investigator, may impact continued suitability for receiving combination nivolumab\u002Fcabozantinib treatment\n  * Participants with treated brain metastases must have discontinued steroid treatment at least 14 days prior to step 2 registration\n  * Participants must not have received investigational agents or monoclonal antibodies (except Food and Drug Administration \\[FDA\\] approved supportive care antibodies, such as denosumab) within 28 days prior to step 2 registration\n  * Participants must not have received surgery, chemotherapy, radiation therapy, biologic agents, or steroids within 14 days prior to step 2 registration\n  * Participants must not have received administration of a live, attenuated vaccine within 30 days prior to step 2 registration. Note: Participants may have received a messenger ribonucleic acid (mRNA) or viral vector-based coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inducers, such as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort, within 14 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inhibitors, such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin, within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration\n  * Participants must have a history and physical examination performed within 28 days prior to step 2 registration\n  * Leukocytes \\>= 3,000\u002FuL (within 28 days prior to step 2 registration)\n  * Absolute neutrophil count \\>= 1,500\u002FuL (within 28 days prior to step 2 registration)\n  * Platelets \\>= 100,000\u002FuL (within 28 days prior to step 2 registration)\n  * Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN for participants with Gilbert's disease (within 28 days prior to step 2 registration)\n  * Aspartate aminotransferase (AST) =\\\u003C 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Urinalysis: For baseline value (no required value for eligibility)\n  * Measured (OR calculated) creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 registration","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are \"tumor mutational burden\" and \"tumor inflammation signature.\" Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Melanoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Melanoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Unresectable Melanoma","RECRUITING","2026-06-25",{"date":54,"type":55},"2026-06-26","ACTUAL",{"date":57,"type":55},"2022-12-06",{"date":59,"type":20},"2027-01-01",{"name":61,"class":62},"National Cancer Institute (NCI)","NIH",223,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100495186","phase-3-study-to-investigate-lifileucel-regimen-plus-pembrolizumab-compared-with-pembrolizumab-alone-in-participants-with-untreated-advanced-melanoma-100495186","NCT05727904","Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.","A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.\n2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.\n4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.\n5. Participants must have adequate organ function.\n6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.\n7. Participants who are \\> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal\u002Focular origin.\n2. Participant has symptomatic untreated brain metastases.\n3. Participant received more than 1 prior line of therapy.\n4. Participant received prior therapy for metastatic disease\n5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant\u002Fneoadjuvant ICI therapy only\n6. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).\n8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \\>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)\n9. Participant has a history of allogeneic cell or organ transplant.\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply.","70 Years",{"count":73,"type":20},670,[75],"PHASE3","This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.",[38,50,78],"Melanoma",[80,81,38,50,82,83,84,85,86,78,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Tumor Infiltrating Lymphocytes","TIL","Cell Therapy","Cellular Immuno-therapy","IL-2","Non-myeloablative lymphodepletion (NMALD)","Check point inhibitor","Lifileucel","Stage III Melanoma","Stage IV Melanoma","Skin cancer","Skin cancer types","Malignant melanoma","Autologous Adoptive Cell Therapy","Autologous Adoptive Cell Transfer","LN-144","Pembrolizumab","Pembro","Adjuvant\u002FNeo-adjuvant","BRAF\u002FMEK","ICI","BRAF v600","Immune checkpoint inhibitor","Tumor infiltrating T-cells","TILVANCE","TILVANCE-301","2026-06-23",{"date":54,"type":55},{"date":109,"type":55},"2023-03-30",{"date":111,"type":20},"2030-03-01",{"name":113,"class":114},"Iovance Biotherapeutics, Inc.","INDUSTRY",81,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":235},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol\n\n  * NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test =\\\u003C 7 days prior to pre-registration for persons of childbearing potential. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained =\\\u003C 28 days prior to pre-registration:\n\n  * Hemoglobin \\>= 9.0 g\u002FdL (Must be \\>= 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 or \\>= 1.5 X 10\\^9\u002FL\n  * Platelet count \\>= 100,000\u002Fmm\\^3 or \\>= 100 X 10\\^9\u002FL (Must be \\>=7 days after most recent transfusion)\n  * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3 x ULN or =\\\u003C 5 x ULN with liver metastases\n  * Creatinine =\\\u003C 1.5 x ULN OR calculated creatinine clearance must be \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease \\>= 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor \\>= 2 cm on pre-surgery evaluation imaging (residual disease \\>= 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing\n\n  * NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test ≤7 days prior to pre-registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive \\>= 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction =\\\u003C 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke =\\\u003C 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in =\\\u003C 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major Surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n  * Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002Fribonucleic acid (RNA)\u002Fdeoxyribonucleic acid (DNA) quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are \\>= 2 cores with passing cellularity; (3) \\>= 30% of tumor RNA with fragment sizes are \\>= 200 base pairs (DV200 \\>= 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Requirement for systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in","16 Years",{"count":126,"type":20},132,[128,23],"PHASE1","This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[131,132,133,134,135,26,136,137,138,28,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,35,169,170,171,38,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,50,216,217,218,219,220,221,222,223,224,225],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","2026-06-18",{"date":106,"type":55},{"date":229,"type":55},"2022-03-31",{"date":231,"type":20},"2028-03-31",{"name":233,"class":234},"Mayo Clinic","OTHER",1,{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100508163","phase-1-immunotherapy-in-combination-with-prednisone-and-sirolimus-for-kidney-transplant-recipients-with-unresectable-or-metastatic-skin-cancer-100508163","NCT05896839","Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer","A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers","Inclusion Criteria:\n\n* Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis\n* Patient's age must be \\>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of nivolumab and ipilimumab in kidney transplant recipients \\\u003C18 years of age, children are excluded from this study, but may be eligible for future pediatric trials\n* Patients must have histologically or cytologically confirmed non-uveal melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma for which standard non-immunological medical, surgical, or radiation therapy would be insufficient (i.e., patients who are not surgical candidates). Patients with cutaneous squamous cell carcinoma or Merkel cell carcinoma may enroll without prior medical therapy (e.g., cetuximab or chemotherapy respectively). Non-immunologic standard therapies that patients must have received, refused or for which patients were ineligible include:\n\n  * For patients with BRAF-mutant melanoma, prior therapies include BRAF\u002FMEK inhibitors\n  * For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors\n* Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, i.e., at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm by chest x-ray or as \\>= 10 mm with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam is preferred, but not required\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%) performance status criteria\n* Leukocytes \\>= 2,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN\n* Serum creatinine =\\\u003C 3 x ULN\n* dd-cfDNA =\\\u003C 1.0% and =\\\u003C 61% increase\n* The effects of nivolumab and ipilimumab on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential (WOCBP) receiving nivolumab must continue contraception for a period of 5 months after the last dose of nivolumab. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.\n\nWOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[B-HCG\\]) during the screening period. Follow-up evaluations will include interval sexual\u002Fmenstrual histories as needed.\n\nShould a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately.\n\nWOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL to be considered postmenopausal.\n\n* Human immunodeficiency virus (HIV)-infected patients will be eligible for this trial if they are on effective antiretroviral regimens utilizing non-CYP-interactive agents and have an undetectable viral load. If there is evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated. If there is history of hepatitis C virus (HCV) infection, the patient must have been treated and have undetectable HCV viral load.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have received a liver, lung, heart, or pancreas transplant; or allogeneic stem cell transplant; or any kind of bone marrow transplant\n* Patients unwilling or unable to undergo dialysis in the event of allograft failure\n* Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA donor-specific antibodies (DSA)\n* Patients with a history of antibody- or cell-mediated allograft rejection within 3 months of study entry\n* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy\u002Fintervention prior to enrollment\n* Patients may have received prior anti-PD-(L)1 therapy; however, patients must not have any other checkpoint antibody targeting T-cell co-stimulation within 1 year of study enrollment. Prior history of adjuvant therapy is allowed if received over 1 year prior to enrollment. Prior receipt of oncolytic therapy (e.g., TVEC, RP1) is allowed\n* Patients must not be receiving any other investigational agents\n* Patients with leptomeningeal metastases, more than 3 untreated central nervous system (CNS) metastases, untreated brain metastases measuring \\>1cm, or requiring treatment-dose steroids (\\> 10 mg\u002Fday prednisone equivalents) for CNS-related symptoms. Exclusions are due to concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs. Patients with brain metastases meeting the above requirements are permitted to enroll\n* Patients must not have a history of severe hypersensitivity reaction to any monoclonal antibody\n* Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study\n* Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because nivolumab and ipilimumab have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with nivolumab or ipilimumab. These potential risks may also apply to other agents used in this study\n* Patients with autoimmune disease that is active or might recur and affect vital organ function will be eligible only after consultation with the study PI. Guillain-Barre (GB) syndrome, bullous skin disease, Stevens Johnson syndrome, or toxic epidermal necrolysis will be excluded\n* Patients must not have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study. In addition, patients with a history of cardiac disease including coronary artery disease (CAD), myocardial infarction (MI), cardiomyopathy, arrhythmia, heart block, should have an evaluation by history pulmonary embolism (PE) and appropriate testing to allow evaluation of any events that may occur on study. These may include troponin, electrocardiogram (EKG), echocardiogram (ECHO) as clinically indicated and may include results already in the medical record if available",{"count":244,"type":20},16,[128,23],"This phase II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while also keeping the transplanted kidney healthy, in patients with unresectable or metastatic cutaneous cancer who have received a kidney transplant.",[26,248,28,249,250,251,38,172,174,252,50,216,218],"Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8","Metastatic Basal Cell Carcinoma","Metastatic Carcinoma in the Skin","Unresectable Basal Cell Carcinoma","2026-06-12",{"date":255,"type":55},"2026-06-15",{"date":257,"type":55},"2024-07-24",{"date":259,"type":20},"2027-01-31",{"name":61,"class":62},26,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100588387","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-iov-3001-in-adults-with-advanced-melanoma-who-will-receive-lifileucel-100588387","NCT06940739","A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel","A Phase 1\u002F2, Open-label Study of a Modified Interleukin-2 Fusion Protein (IOV-3001) in Participants With Previously Treated, Unresectable or Metastatic Melanoma Who Will Receive Lifileucel","Inclusion Criteria:\n\n1. Participant must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participant has unresectable or metastatic melanoma.\n3. Participant has melanoma not of uveal\u002Focular origin and experienced documented radiographic disease progression during systemic therapy with a PD-1\u002FPD-L1 blocking antibody or within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody. If the tumor is BRAF V600 mutation positive, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.\n\n   OR Phase 1, Part 1 only: For participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen \\[HLA\\]-A\\*02:01 positive participant and approved by local authorities for uveal melanoma) or refused.\n4. Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \\> 6 months.\n5. Phase 1, Part 2 only: Following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has recovered from all prior anticancer treatment-related AEs\n\nExclusion Criteria:\n\n1. Participant has symptomatic untreated brain metastases.\n2. Participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n3. Participant has active uveitis that requires active treatment.\n4. Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \\[SCID\\] or AIDS).\n5. Participant has a history of hypersensitivity to any component of the study intervention.\n6. Participant had another primary malignancy within the previous 3 years.\n7. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n8. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.",{"count":270,"type":20},42,[128,23],"A Phase 1\u002F2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.",[50,38,274],"Ocular Melanoma",[80,81,50,38,82,93,83,84,94,78,87,89,276,277],"Malignant Melanoma","Uveal Melanoma","2026-06-11",{"date":255,"type":55},{"date":281,"type":55},"2025-03-11",{"date":283,"type":20},"2032-07",{"name":113,"class":114},5,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100467009","phase-1-a-study-to-investigate-the-efficacy-and-safety-of-an-infusion-of-iov-4001-in-adult-participants-with-unresectable-or-metastatic-melanoma-or-stage-iii-or-iv-non-small-cell-lung-cancer-100467009","NCT05361174","A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","A Phase 1\u002F2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.\n2. Participants who have received the following previous therapy:\n\n   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1\u002FPD-L1 blocking antibody and received BRAF\u002FMEK inhibitor in those with BRAF mutations.\n   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:\n\n      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n      * those with oncogene-driven tumors: Have progressed during\u002Fafter ≥1 targeted therapy AND either:\n\n        * platinum doublet chemotherapy\n        * Or within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Participants who is assessed as having at least one resectable lesion.\n5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.\n6. Participants who have adequate organ function.\n7. Cardiac function test required.\n8. Pulmonary function test may be required.\n9. Participants 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 up to 12 months.\n10. Participants who are \\>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participants who have melanoma of uveal\u002Focular origin.\n2. Participants who have symptomatic untreated brain metastases.\n3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n4. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n5. Participants who have any form of primary immunodeficiency.\n6. Participants who have another primary malignancy within the previous 3 years.\n7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.",{"count":294,"type":20},53,[128,23],"This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).",[50,38,298,299],"Stage III Non-small Cell Lung Cancer","Stage IV Non-small Cell Lung Cancer",[80,81,50,38,301,302,303,82,93,83,84,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,86,321,322,323,324,94,78,87,88,89,90,91,92],"Stage III Non-small-cell lung cancer","Stage IV Non-small-cell lung cancer","PD-1 Knockout","Non Small Cell Lung Cancer","NSCLC","Second line Lung Cancer","Bronchial Neoplasms","Carcinoma","Lung Disease","Metastatic Lung Cancer","Metastatic Non Small Cell Lung Cancer","Lung Carcinoma","PD-L1","Stage IV Cancer","Stage IV Lung Cancer","Stage IV NSCLC","Systemic Therapy","2nd line therapy","Second line therapy","CPI","Metastatic NSCLC","NSCLC Recurrent","Recurrent Lung Cancer","Recurrent Lung Carcinoma","2026-06-10",{"date":278,"type":55},{"date":328,"type":55},"2022-07-20",{"date":330,"type":20},"2029-09",{"name":113,"class":114},11,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":235},"100641091","phase-1-dual-target-cspg4gd2-car-nk-cells-for-advanced-melanoma-100641091","NCT07627698","Dual-Target CSPG4\u002FGD2 CAR-NK Cells for Advanced Melanoma","An Open-Label, Multicenter Phase 1\u002F2 Study of Allogeneic Dual-Target CSPG4\u002FGD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma","DUET-MEL","Inclusion Criteria:\n\n* Age 18-75 years at consent.\n* Histologically confirmed unresectable\u002Fmetastatic cutaneous melanoma or metastatic uveal melanoma.\n* Disease progression after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit. For cutaneous melanoma: prior anti-PD-1\u002FL1 (with or without antiCTLA-4) unless contraindicated; if BRAF V600-mutant, prior BRAF\u002FMEK inhibitor therapy or documented unsuitability. For uveal melanoma: prior tebentafusp if HLA-A\\*02:01-positive and eligible, or documented unsuitability\u002Funavailability plus at least one prior systemic therapy.\n* Tumor demonstrates CSPG4 and\u002For GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable tumor cells by IHC or equivalent validated assay).\n* At least 1 measurable lesion by RECIST v1.1.\n* ECOG performance status 0-1.\n* Adequate bone marrow, renal, hepatic, cardiac, and pulmonary function per protocol.\n* Life expectancy of at least 12 weeks.\n* Treated, stable brain metastases are allowed if neurologically stable for at least 4 weeks and not requiring escalating corticosteroids.\n* Willingness to use effective contraception and comply with protocol-required visits, blood sampling, and requested biopsies.\n\nExclusion Criteria:\n\n* Active symptomatic CNS metastases, leptomeningeal disease, or uncontrolled seizure disorder.\n* Prior allogeneic stem cell transplant or solid organ transplant; prior gene-modified cellular therapy within 12 weeks; or anti-cancer therapy too close to lymphodepletion per protocol washout rules.\n* Requirement for systemic immunosuppression greater than 10 mg prednisone equivalent\u002Fday or uncontrolled autoimmune\u002Finflammatory disease requiring systemic treatment.\n* Active uncontrolled infection, including uncontrolled HIV, HBV, or HCV, or fever\u002Fsepsis at the time lymphodepletion would begin.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, recent myocardial infarction, or uncontrolled thromboembolic disease.\n* Grade 2 or higher unresolved toxicities from prior therapy, except stable endocrinopathy, alopecia, or vitiligo.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or CAR-NK infusion unsafe.","75 Years",{"count":343,"type":20},36,[128,23],"This is a first-in-human, open-label, multicenter phase 1\u002F2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4\u002FGD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy",[50,347,348],"Metastatic Cutaneous Melanoma","Metastatic Uveal Melanoma",[350,351,352,353,354,355,356,357,358],"CAR-NK","allogeneic NK cells","CSPG4","GD2","advanced melanoma","uveal melanoma","cell therapy","biomarker-guided","solid tumor","2026-05-31",{"date":361,"type":55},"2026-06-04",{"date":363,"type":55},"2026-03-02",{"date":365,"type":20},"2028-06-17",{"name":367,"class":114},"Beijing Biotech",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":377,"briefSummary":378,"conditions":379,"keywords":383,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100564090","phase-2-a-trial-of-lns8801-with-or-without-pembrolizumab-in-patients-with-refractory-melanoma-100564090","NCT06624644","A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma","A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma","Inclusion Criteria:\n\n* Confirmed unresectable and\u002For metastatic cutaneous melanoma.\n* 2 copies of the fully functional form of GPER protein-coding sequence.\n* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.\n* Able to swallow tablets.\n* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.\n* Received an anti-CTLA-4 and\u002For BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and\u002For BRAF therapy prior to and for this study.\n* Measurable disease.\n* Eastern Cooperative Oncology Group Performance Status of 0 to 1.\n\nExclusion Criteria:\n\n* Blue nevus subtype, mucosal, acral lentiginous, or uveal\u002Focular\u002Fchoroidal Melanoma.\n* Previous anti-cancer or investigational drug\u002Fdevice treatment within 4 weeks of the first dose of study drug.\n* Radiotherapy within 2 weeks of starting study drug.\n* Allogeneic tissue\u002Fsolid organ transplant.\n* Unstable autoimmune or immunodeficiency disease.\n* Other concurrent health issues that would make participation or completion of the study difficult.\n* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":376,"type":20},135,[23,75],"The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.\n\n135 patients will be randomly (like flipping a coin) placed in 3 treatment groups.\n\nIn the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years.\n\nIn the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years.\n\nIn the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab\u002Frelatlimab or nivolumab\u002Fipilimumab) as determined by their treating physician.\n\nHow often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.",[380,381,382,50],"Melanoma (Skin Cancer)","Melanoma Stage IIIB-IV","Cutaneous Melanoma",[78],"2026-04-18",{"date":386,"type":55},"2026-04-22",{"date":388,"type":55},"2025-08-06",{"date":390,"type":20},"2031-02",{"name":392,"class":114},"Linnaeus Therapeutics, Inc.",9,{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":400,"phases":4,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":406,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":410,"locationsCount":411},"100469886","expanded-access-program-of-amtagvi-that-is-out-of-specification-for-commercial-release-100469886","NCT05398640","Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release","Inclusion Criteria:\n\n1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)\n2. Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk\u002Fbenefit assessment\n3. 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 the last protocol-related therapy\n\nExclusion Criteria:\n\n1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium\n2. Ongoing systemic infection\n3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician\n4. Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2\n5. Any other condition, laboratory abnormality and\u002For pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment\n6. Pregnant or breastfeeding","EXPANDED_ACCESS","The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.",[50,38],[95,87,404,82,80,81,405],"Adoptive Cell Therapy","Immunotherapy","AVAILABLE","2026-04-16",{"date":409,"type":55},"2026-04-20",{"name":113,"class":114},48,{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":21,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":235},"100551926","phase-2-prebiotic-food-enriched-diet-prefed-to-enhance-the-microbiome-and-response-to-first-line-immunotherapy-in-unresectable-melanoma-100551926","NCT06466434","Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma","Inclusion Criteria:\n\n* Age ≥18 years old\n* English-speaking\n* Body mass index (BMI) 18.5-45 kg\u002Fm2\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically confirmed stage III\u002FIV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.\n* Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +\u002F- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.\n* Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)\n* Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.\n* WOCP must have negative UPT within 1 week of beginning dietary intervention.\n* Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)\n* Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.\n\nExclusion Criteria:\n\n* Previous ICB treatment in the metastatic setting\n* History of inflammatory bowel disease, total colectomy, or bariatric surgery.\n* Currently taking steroids \\> Prednisone 10 mg\u002Fday or equivalent\n* Medical contraindications to the Intervention Diet as determined by the treating physician.\n* Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.\n* Insulin-dependent diabetes or condition requiring bile acid sequestrants\n* Unable or unwilling to undergo study procedures.\n* IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.\n* Regularly taking supplements containing prebiotics, fiber and\u002For probiotics, and unable\u002Funwilling to discontinue for the purpose of the study.\n* Current smoker or heavy drinker (defined as \\>14 drinks per week) or current illicit drug use.\n* Currently pregnant, planning to become pregnant, or lactating.\n* Concurrent malignancy requiring systemic therapy other than hormonal therapy.\n* Cognitively impaired adults",{"count":419,"type":20},75,[23],"To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.",[50],"2026-03-23",{"date":425,"type":55},"2026-03-24",{"date":427,"type":55},"2024-09-01",{"date":429,"type":20},"2029-06-30",{"name":431,"class":234},"M.D. Anderson Cancer Center",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":439,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":452,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":462},"100628277","phase-4-a-study-to-assess-the-safety-and-tolerability-of-nivolumab--relatlimab-fixed-dose-combination-fdc-in-untreated-unresectable-or-metastatic-melanoma-participants-in-india-100628277","NCT07459543","A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India","A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.","Inclusion Criteria\n\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\u002FLansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.\n* Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition).\n* Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).\n* Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n* Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration.\n* Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.\n\nExclusion Criteria\n\n* Participants must not have active brain metastases or leptomeningeal metastases.\n* Participants must not have uveal melanoma.\n* Participants must not have an active, known, or suspected autoimmune disease.\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.\n* Participants must not have a history of myocarditis.\n* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","12 Years",{"count":441,"type":20},30,[443],"PHASE4","The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India",[446,50,38],"Untreated Melanoma",[448,276,405,449,450,451],"Skin Cancer","India","Nivolumab","Relatlimab","NOT_YET_RECRUITING","2026-03-05",{"date":455,"type":55},"2026-03-09",{"date":457,"type":20},"2026-11-15",{"date":459,"type":20},"2029-05-28",{"name":461,"class":114},"Bristol-Myers Squibb",8,{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":472,"phases":4,"briefSummary":473,"conditions":474,"keywords":477,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":235},"100531431","correlating-early-fdg-petct-and-ctdna-in-immune-checkpoint-inhibitor-ici-treated-melanoma-patients-100531431","NCT06199713","Correlating Early FDG PET\u002FCT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients","Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Willing to provide informed consent.\n* Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and\u002For pembrolizumab, either alone or in combination with other ICI therapy, is planned.\n* Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.\n* Individuals at least 18 years of age.\n* Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.\n* Willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n* Not able to receive treatment with ICI therapy\n* Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.\n* Women who are pregnant, lactating, or planning on becoming pregnant during the study.\n* Not suitable for study participation due to other reasons at the discretion of the investigators.",{"count":471,"type":20},24,"OBSERVATIONAL","The purpose of this research study is to determine if analysis of PET\u002FCT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.",[78,475,476,50],"Melanoma Stage III","Melanoma Stage IV",[478,479,100],"circulating tumor DNA","FDG","2026-01-15",{"date":482,"type":55},"2026-01-20",{"date":484,"type":55},"2024-01-30",{"date":486,"type":20},"2029-01",{"name":488,"class":234},"University of Wisconsin, Madison",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":21,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":511},"100472140","phase-2-interleukin-6-receptor-inhibitor-sarilumab-in-combination-with-ipilimumab-nivolumab-and-relatlimab-in-patients-with-unresectable-stage-iii-or-stage-iv-melanoma-100472140","NCT05428007","Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma","A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma","Inclusion Criteria:\n\n* Patients must have signed and dated an Institutional Review Board\u002FIndependent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care\n* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n* All patients must be either Stage IIIb\u002Fc\u002Fd or Stage IV according to the American Joint Committee on Cancer (AJCC) (8th edition) and have histologically-confirmed melanoma that is felt to be surgically unresectable in order to be eligible. Please refer to the AJCC Cancer Staging Manual, 8th edition for a description of tumor, lymph node, metastasis and staging.\n\n  * All melanomas, except ocular\u002Fuveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible.\n  * Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical).\n\noExceptions: Surgery for melanoma and\u002For post-resection brain radiotherapy (RT) if central nervous system (CNS) metastases and local radiation for locoregional disease and\u002For prior treatment with adjuvant nivolumab, dabrafenib and trametinib, pembrolizumab, interferon (IFN) or ipilimumab (IPI) (as described in Exclusion Criterion 8,4 full protocol below).\n\n* All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography (CT) scan of chest, abdomen, pelvis, and all known sites of resected disease in the setting of Stage IIIb\u002Fc\u002Fd or Stage IV disease, and brain magnetic resonance imaging (\\[MRI\\]; brain CT is allowable if MRI is contraindicated).\n* Disease must be measurable by RECIST 1.1\n* The complete set of baseline radiographic images must be available before treatment initiation.\n\nExclusion Criteria:\n\n* Patients with untreated brain metastases, carcinomatosis meningitis or current ocular\u002Fuveal melanoma are excluded.\n* Patients with previous non-melanoma malignancies are excluded unless a complete resection or 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 (exceptions include, but are not limited to, non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers\u002Fdysplasia, or breast carcinoma in situ).\n* Patients with active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease","100 Years",{"count":498,"type":20},105,[23],"This study will evaluate how safe the study drug is, how well patients tolerate it, how it works in the body, and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients like yourself, with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for your type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA. The combination of sarilumab, ipilimumab, nivolumab and relatlimab is considered investigational because it has not yet been approved by the FDA. The FDA has given its permission to study the investigational combination of these drugs in this research study.",[78,50],"2025-12-31",{"date":504,"type":55},"2026-01-05",{"date":506,"type":55},"2023-02-02",{"date":508,"type":20},"2028-02",{"name":510,"class":234},"NYU Langone Health",4]