[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-stage-iii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,40,80,106,131,152,179,202,227,255,275,303,330,355,375,398,420,444,466],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100636407","phase-2-the-efficacy-and-safety-of-prtx007-003-combined-with-pembrolizumab-in-resectable-stage-iii-melanoma-100636407",false,"NCT07565285","The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma","A Phase 2 Study to Investigate the Activity of Neoadjuvant PRTX007 Combined With Pembrolizumab in Participants With Stage III Melanoma (INFLECTION-003)","INFLECTION-003","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Histologically confirmed, resectable Stage III cutaneous melanoma.\n* Candidate for curative-intent surgical resection\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior systemic therapy for melanoma, including immunotherapy\n* Uveal melanoma or mucosal melanoma.\n* Active autoimmune disease requiring systemic treatment\n* Primary immunodeficiency or use of systemic immunosuppressive therapy\n* Women who are pregnant or breastfeeding\n* Recent treatment with another investigational therapy\n* Any condition that, in the opinion of the investigator, would interfere with study participation or safety","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Neoadjuvant immunotherapy has demonstrated improved clinical outcomes compared with adjuvant-only approaches, but there remains a need to enhance pathologic response rates without significant added toxicity.\n\nParticipants will receive oral PRTX007, a Toll-like receptor 7 (TLR7) agonist prodrug, administered in combination with intravenous pembrolizumab prior to surgical resection. The primary objective is to determine the major pathologic response (MPR) rate following neoadjuvant therapy. Secondary objectives include evaluation of safety, pathologic complete response, event-free survival, overall survival, pharmacokinetics, and immune-related biomarkers.\n\nThis study aims to determine whether the addition of PRTX007 to pembrolizumab improves antitumor immune responses and clinical outcomes in patients with Stage III melanoma.",[27],"Melanoma Stage III","NOT_YET_RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":21},"2026-07-01",{"date":36,"type":21},"2029-06",{"name":38,"class":39},"Primmune Therapeutics, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100489606","phase-1-mc1r-targeted-alpha-particle-monotherapy-and-combination-therapy-trial-with-nivolumab-in-adults-with-advanced-melanoma-100489606","NCT05655312","MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma","A Phase I\u002FIIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Finding and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n* Ability to understand and willingness to provide informed consent, willingness to comply with all study procedures for the duration of the study\n* Aged ≥ 18 years\n* Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma\n* Previously progressed (radiological progression) on at least one approved systemic therapy for advanced melanoma\n* Uptake of \\[68Ga\\]VMT02 or \\[203Pb\\]VMT01 by PET or SPECT imaging observed in at least one melanoma tumor site using quantitative imaging analysis compared to reference normal tissue\n* Subjects on prior intravenous therapy (e.g., chemotherapy or checkpoint inhibitors), or prior oral therapy (e.g.,proto-oncogene B-RAF or mitogen-activated extracellular signal-regulated kinase inhibitors) who demonstrate MC1R positivity during screening are eligible for enrollment, provided that they undergo a wash-out period of 21 days, or 7 days, respectively, prior to Cycle 1 Day 1 treatment with \\[212Pb\\]VMT01.\n* Presence of measurable disease by RECIST v1.1 assessed within 45 days prior to the first dose of \\[212Pb\\]VMT01 on Cycle 1 Day 1\n* Ability to lie flat and still for up to two hours for imaging scans; moderate conscious sedation allowed if indicated\n* For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment with \\[212Pb\\]VMT01 and\u002For nivolumab, and for at least 6 months after the last dose of \\[212Pb\\]VMT01 and\u002For nivolumab, whichever is administered last\n* For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception and refrain from donating sperm starting from screening, during treatment with \\[212Pb\\]VMT01 and\u002For nivolumab, and for at least 6 months after the last dose of \\[212Pb\\]VMT01 and\u002For nivolumab, whichever is administered last\n* Eastern Cooperative Oncology Group performance score of \\\u003C 2 at Screening\n* Life expectancy of at least 3 months after Cycle 1 Day 1\n* Satisfactory organ function determined by laboratory testing\n\nExclusion Criteria:\n\n* Active secondary malignancy\n* Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled\n* Pregnancy or breastfeeding a child\n* Any serious\u002Factive\u002Funcontrolled infection requiring parenteral antibiotics within 2 weeks before the first administration of \\[212Pb\\]VMT01\n* Febrile illness within 48 hours of any scheduled investigational product (\\[212Pb\\]VMT01, \\[203Pb\\]VMT01, or \\[68Ga\\]VMT02) administration; subjects should be rescheduled \\> 48 hours after resolution of fever\n* Treatment with another investigational drug product (therapeutic IND agents) within the last 45 days before the first dose of \\[212Pb\\]VMT01 on C1D1.\n* Current abuse of alcohol or illicit drugs\n* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions\n\nAdditional exclusion criteria for subjects who will receive combination therapy with nivolumab:\n\n* Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality. Subjects must have been either off corticosteroids, or on a stable or decreasing dose of prednisone (or equivalent) for at least 2 weeks prior to the first dose of \\[212Pb\\]VMT01\n* Subjects with an active, known, or suspected autoimmune disease\n* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications\n* Acute or chronic hepatitis B (e.g., Hepatitis B surface antigen reactive), hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected) or known history of Human Immunodeficiency Virus (HIV) with an acquired immunodeficiency syndrome\n* Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines)\n* Existence of abnormal laboratory values in hematology, liver, and renal function\n* Treatment with any live\u002Fattenuated vaccine within 30 days prior to the first dose of \\[212Pb\\]VMT01\n* Any treatment-related toxicities from prior systemic immune therapy with the exception of those unlikely to re-occur with standard countermeasures\n* History of allergy or hypersensitivity to nivolumab or its components","90 Years",{"count":49,"type":21},300,[51,24],"PHASE1","In this first-in human, phase I\u002FIIa study, the safety and efficacy of \\[212Pb\\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.",[54,55,56,27],"Recurrent Melanoma (Skin)","Metastatic Melanoma","Melanoma Stage IV",[58,59,60,61,62,63,64,65,66,67,68],"Melanoma","Theranostic","Radiopharmaceutical","Radiotherapy","Alpha Particle","Melanocortin Receptor Sub-type 1 (MC1R)","VMT01-T101","Pb-203","Pb-212","Ga-68","Nivolumab","RECRUITING","2026-06-08",{"date":72,"type":32},"2026-06-10",{"date":74,"type":32},"2023-06-01",{"date":76,"type":21},"2029-12-31",{"name":78,"class":39},"Perspective Therapeutics",13,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100408402","phase-2-binimetinib-and-imatinib-for-unresectable-stage-iii-iv-kit-mutant-melanoma-100408402","NCT04598009","Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma","A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Have histologically or cytologically confirmed melanoma\n* Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy\n* Have measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria\n* Have documentation of KIT-mutant melanoma by Clinical Laboratory Improvement Act (CLIA)-certified testing platform\n* Participants have progressed on prior standard-of-care therapy, or would be ineligible for or unable to tolerate standard-of-care therapy, in the opinion of the treating Investigator\n* For participants who have received prior ICI, the following is permitted:\n\n  * Prior adjuvant or neoadjuvant ICI, if last dose administered at least 4 weeks prior to study drug start\n  * Prior ICI for the treatment of unresectable\u002Fmetastatic disease, if last dose administered at least 4 weeks prior to study drug start\n* Absolute neutrophil count \\>= 1,500\u002Fmicroliter (mcL)\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin below normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 x institutional upper limit of normal\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin calculated using the Cockcroft-Gault formula\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy, with undetectable viral load within 3 months of study drug start, are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS)-specific treatment is not required prior to study start\n* Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Imatinib and\u002For binimetinib may have teratogenic effects. Women of child-bearing potential (WOCBP) must agree to:\n\n  * Use highly effective contraception to avoid pregnancy from screening through 30 days after the last dose of study drugs;\n  * Refrain from donating ova during the study through 30 days after the end of systemic exposure to study drugs;\n  * Inform her treating physician immediately should she become pregnant or suspect she is pregnant while she is participating in this study\n* Sexually active men enrolled on this protocol must agree to:\n\n  * Use a condom for the duration of study participation and through 90 days after the end of systemic exposure to study drugs;\n  * Refrain from donating sperm during the study through 90 days after the end of systemic exposure to study drugs;\n  * If the male participant has a partner that is a WOCBP, that partner should also use highly effective contraception for the duration of the study and through 90 days after the end of the male participant's systemic exposure to study drug\n  * Inform his treating physician immediately should his partner become pregnant while he is participating in this study\n\nHighly effective (i.e., failure rate \\\u003C1% per year when used consistently and correctly) methods of contraception include:\n\n* Complete abstinence from heterosexual intercourse\n* Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n* Intra-uterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomized male partner (provided the vasectomized male has received medical assessment of surgical success, and that the male is a female participant's sole sexual partner)\n\n  * Ability to understand a written informed consent document, and the willingness to sign it\n  * The participant is deemed by the Investigator to have the initiative and means to be compliant with scheduled visits, treatment plan, and study procedures\n\nExclusion Criteria:\n\n* Has received systemic anti-cancer therapies within 3 weeks of study drug start, radiation within 2 weeks, antibody therapy within 4 weeks\n* Has not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline. Note: Stable chronic conditions (grade =\\\u003C 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll\n* Is currently receiving any other investigational agents or has received an investigational agent within 14 days or within 5 half-lives of investigational agent (whichever is shorter), prior to start of study drugs\n* Inability to swallow and retain study drugs\n* Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drugs (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, complete small bowel resection), or recent (=\\\u003C 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs\n* Hypersensitivity to binimetinib or any of its excipients\n* Hypersensitivity to imatinib or any of its excipients\n* Concurrent neuromuscular disorder that is associated with elevated creatinine-kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity of hypercoagulability syndromes); history of retinal degenerative disease\n* Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty of stenting) \\\u003C 6 months prior to screening;\n  * Congestive heart failure requiring treatment (New York Heart Association grade \\>= 2);\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO);\n  * Uncontrolled hypertension defined as persistent systolic blood pressure \\>= 150 mmHg or diastolic blood pressure \\>= 100 mmHg despite current therapy;\n  * History of presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Triplicate average baseline corrected QT (QTc) interval \\>= 480 msec\n* Use of a prohibited medication (including herbal medications, supplements, or foods) that cannot be safely discontinued prior to the start of study treatment\n* Patients on warfarin who cannot be safely transitioned to an alternative systemic anticoagulant\n* History of thromboembolic or cerebrovascular events =\\\u003C 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks prior to study drug start. Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled\n* Pregnant women are excluded from this study because binimetinib and imatinib are small molecule inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with binimetinib and\u002For imatinib, breastfeeding should be discontinued prior to study drug start\n* Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study",{"count":88,"type":21},25,[24],"This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.",[27,56],[93,94,58],"KIT-Mutant","Unresectable Melanoma","2026-06-02",{"date":97,"type":32},"2026-06-04",{"date":99,"type":32},"2021-03-03",{"date":101,"type":21},"2028-05-31",{"name":103,"class":104},"University of California, San Francisco","OTHER",2,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100538770","phase-2-neoadjuvant-and-adjuvant-anti-pd1-or-combinations-for-locoregionally-advanced-melanoma-100538770","NCT06295159","Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma","Inclusion Criteria:\n\n* This study is divided into 2 sub-studies\u002Fparts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2. In Part 2, Part 2 Cohort A and Part 2 Cohort B will enroll simultaneously. Inclusion criteria apply to Part 1 and Part 2 unless otherwise specified.\n* Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n* 18 years of age or older\n* Histologic diagnosis of melanoma (cutaneous, acral, mucosal or unknown primary) belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages (Tx or T1-4) and (N1b, N1c, N2b, N2c, N3b or N3c) and\u002For (M1a).\n* Requirements for prior systemic therapy for melanoma are as follows:\n\n  1. Sub-study Part 1: No prior systemic therapy for melanoma (N=30).\n  2. Sub-study Part 2 Cohort A: No prior systemic therapy for melanoma (N=20)\n  3. Sub-study Part 2 Cohort B: Locoregionally advanced melanoma that is refractory to systemic adjuvant therapy (anti-PD1-based or BRAF-MEK inhibitors) (N=40).\n\nThis excludes patients who previously received adjuvant or neoadjuvant anti-PD1 plus anti-LAG3 or anti-PD1 plus anti-CTLA4.\n\nParticipants who experienced progression or recurrence after anti-PD1 as monotherapy or other combinations or after BRAF-MEK inhibition would be eligible.\n\nParticipants who have previously experienced prior high-grade (grade 3 or 4 by CTCAE criteria) immune related adverse events with immune checkpoint inhibitors are not eligible.\n\n* Must be considered surgically operable and may present as any of the following groups:\n\n  1. Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.\n  2. Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.\n  3. Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.\n  4. Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.\n  5. Participants with in-transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.\n  6. Participants with distant cutaneous\u002Fsubcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied at Screening by the treating surgical oncologist. Elevated LDH is not an exclusion.\n  7. Elevated LDH is not an exclusion.\n* Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and\u002For in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)\n* Participants must provide a sufficient and adequate formalin-fixed paraffin-embedded (FFPE) tumor tissue sample from the most recent biopsy of a tumor lesion, obtained within 90 days from signing informed consent form (ICF). If recent tumor tissue is unavailable or inadequate, a fresh biopsy will be required, unless the principal investigator agrees that it is not safe\u002Ffeasible.\n* Participants must be evaluated by standard-of-care full body imaging studies, the choice of which is decided by the treating physician investigator.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) in accordance with the standard of care for WOCBP.\n* WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 5 months after the last dose of study treatment. Highly effective contraception is as stipulated in national or local guidelines.\n* Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 5 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n* Willing and able to comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Treatment with another investigational drug or other systemic intervention for melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 2 weeks. Patients must have recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participants must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection.\n* Ocular or uveal melanoma.\n* Bowel obstruction or impending bowel obstruction within the past 3 months.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure or serious uncontrolled cardiac arrhythmia requiring medication.\n* Active or history of brain metastases or leptomeningeal metastases.\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, i.e., patients with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the patient has no evidence of disease. Participants with history of prior early-stage basal\u002Fsquamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n* Treatment with one of the following classes of drugs within the delineated time window prior to C1D1:\n\n  1. Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.\n  2. mAbs, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.\n  3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \\\u003C 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \\> 7 days from C1D1 or \\> 7 days from future cycle on study.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.\n* History of allogeneic organ transplant.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs.\n* History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* Pregnant or breastfeeding or WOCBP who are not willing to employ effective birth control from screening to 5 months after the last dose of study treatment (whichever is later).\n* Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe\u002Fcritical illness prior to C1D1.\n* Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n* Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required. Known active co-infection with hepatitis B and hepatitis C or with hepatitis B and hepatitis D is an exclusion.\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.\n* Dependence on total parenteral nutrition.\n* Troponin T (TnT) or I (TnI) \\> 2× institutional ULN. Participants with TnT or TnI levels between \\> 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant must undergo a cardiology consultation and cardiac evaluation and be considered for treatment, based on a favorable benefit\u002Frisk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the participant must undergo a cardiology consultation and cardiac evaluation and be considered for treatment, based on a favorable benefit-risk assessment by the Investigator.\n* Left ventricular ejection fraction (LVEF) assessment with documented LVEF \\\u003C 50% by either transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to start of study treatment.\n* Participants with a history of myocarditis and\u002For current diagnosis of myocarditis, regardless of etiology.\n* Participants must not have a history of allergy or hypersensitivity to study intervention components.",{"count":113,"type":21},90,[24],"The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system.\n\nThis study is divided into 2 sub-studies\u002Fparts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2.",[27,56,117,58],"Advanced Melanoma",[58,119,120],"Anti-PD1","Locoregionally Advanced Melanoma","2026-03-31",{"date":123,"type":32},"2026-04-01",{"date":125,"type":32},"2024-05-17",{"date":127,"type":21},"2028-11",{"name":129,"class":104},"H. Lee Moffitt Cancer Center and Research Institute",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":130},"100405648","phase-2-il2-with-ipilimumab-followed-by-nivolumab-in-stage-3-or-4-melanoma-patients-100405648","NCT04562129","IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients","A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic melanoma. This includes American Joint Committee on Cancer (AJCC) stage IV or advanced\u002Finoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally\u002Fregionally advanced\u002Finoperable disease or distant metastases\n* Measurable disease, according to RECIST version 1.1\n* Must be free of active brain metastasis by contrast-enhanced CT\u002FMRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study.\n* Must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) and later experienced disease progression.\n* Must not have received systemic therapy or radiotherapy (including SRS) within the preceding 3 weeks. Patients must have recovered from adverse events from previous therapy by the time registration.\n* Must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery, and must be free of significant detectable infection prior to registration.\n* Patients who have received prior anti-CTLA4 monoclonal antibody therapy (ipilimumab or tremelimumab) are eligible.\n* Patients who have previously experienced prior high-grade (grade 3 or 4 by CTCAE criteria) immune related adverse events with immune checkpoint inhibitors must be discussed with the study PI and cleared prior to enrollment on this study in order to ensure patient safety.\n* Patients with BRAF V600 mutant melanoma must have previously received BRAF targeted therapy for metastatic melanoma and later experienced disease progression. Patients who refuse or decline to receive BRAF targeted therapy or were intolerant of BRAF targeted therapy are eligible.\n* Life expectancy of greater than 3 months in the opinion of the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Must have normal organ and marrow function as specified per protocol.\n* Patients on full-dose anticoagulants with Prothrombin Time Test International Normalized Ratio (PT INR) \\>1.5 are eligible provided that both of the following criteria are met: (a) The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin. (b) The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).\n* Pulmonary: Forced Expiratory Volume at 1 second (FEV1) \\> 2.0 liters or \\> 75% of predicted for height and age. Pulmonary function tests (PFTs) are required for patients over 50 years old or with significant pulmonary or smoking history\n* No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina.\n* Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (CAD or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multigated acquisition scan (MUGA), stress echo or exercise stress test) for cardiac ischemia within 8 weeks prior to registration.\n* No history of cerebrovascular accident or transient ischemic attacks within the past 6 months from registration.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Women should not be lactating and, if of childbearing age, should have a negative pregnancy test (b-HCG test; serum or urine, minimum sensitivity 25 IU\u002FL or equivalent units of b-HCG) within two weeks of registration in the study.\n\nExclusion Criteria:\n\n* Patients who have had systemic therapy for melanoma or radiotherapy within 3 weeks prior to registering on the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. Patients with a history of endocrinopathies (e.g. hypothyroidism) are eligible if they are stable on hormone replacement therapy. Patients with a history of adrenal insufficiency are not eligible.\n* Patients may not be receiving any other investigational agents.\n* Patients with active brain metastasis are excluded\n* Patients with clinically significant cardiovascular or cerebrovascular disease\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have other current malignancies are not eligible. Patients with other malignancies are eligible if they have been continuously disease free for \\> 2 years prior to the time of registration. Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible. Patients with prior history of basal or squamous skin cancer are eligible. Patients who have had multiple primary melanomas are eligible.\n* Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids or steroid inhalers. If a patient had been taking steroids, at least 2 weeks must have passed since the last dose.",{"count":139,"type":21},29,[24],"The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.",[27,56,143],"Inoperable Disease",[145],"skin cancer",{"date":123,"type":32},{"date":148,"type":32},"2020-09-24",{"date":150,"type":21},"2029-11",{"name":129,"class":104},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":130},"100575381","phase-2-metronomic-cyclophosphamide-with-pembrolizumab-in-checkpoint-inhibitor-refractory-melanoma-100575381","NCT06771544","Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent form (ICF)\n* Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy\n* Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator\u002F radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow, liver, and renal function\n* Hemoglobin ≥9.0 g\u002FdL\n* Platelets ≥100\u002Fmm3\n* ANC ≥1.5\u002Fmm3\n* Creatinine Clearance ≥ 30mL\u002Fmin Cockcroft-Gault CrCl, mL\u002Fmin = (140 - age) × (weight, kg) × (0.85 if female) \u002F (72 × Cr, mg\u002FdL).\n* AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin \\\u003C 3.1 mg\u002FdL.\n* Has progressed on a prior PD-1\u002FPD-L1 treatment\n* Recovered from toxicities of pembrolizumab to Grade ≤1, excluding endocrine toxicities\n* Prior Receipt of PD-1\u002FPD-L1 therapy within 9 weeks prior to the first dose of the investigational therapy.\n* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment\n* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of study intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n* Pregnant or lactating women are prohibited from enrolling in this study.\n* Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of ocular or metastatic uveal melanoma\n* Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:\n* Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.\n* Completely resected basal cell and squamous cell skin cancers.\n* Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.\n* Completely resected carcinoma in situ of any type\n* Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with an immune-related adverse event (irAE) of grade 3 or greater\n* Participants with known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the following apply:\n* Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and\u002For radiation).\n* Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.\n* Any prior investigational or standard cancer therapy, with exception of PD-1\u002FPD-L1 (includes nivolumab + Relatlimab) therapy, chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy (see Inclusion Criteria)\n* Presence of B-RAF driver mutation without prior receipt of BRAF +\u002F- MEK inhibitors, unless patient declines BRAF +\u002F-MEK inhibition for any reason or is unable to tolerate BRAF and\u002For MEK inhibitors.\n* Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active infection.\n* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \\> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.\n* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.\n* Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \\>200\u002Fmicroliters as measured within screening time period. If the patient does not have a known history of HIV, then testing is not required during screening to confirm presence or absence of HIV.\n* Positive serum pregnancy test\n* Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \\>7 days from any blood transfusion. Or blood product transfusion or from any dose of hematologic growth factor.\n* Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \\\u003C 30 mL\u002Fmin\n* Total bilirubin \\> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \\> 3.0 × ULN; or direct bilirubin \\> 1.5 × ULN\n* Albumin \\\u003C 3.0 g\u002FdL\n* Absolute lymphocyte count \\\u003C 0.5 × 10\\^9\u002FL\n* Participants with a history of allogeneic tissue\u002Fsolid organ transplant",{"count":159,"type":21},14,[24],"This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.",[58,27,163,56],"Melanoma (Skin)",[58,165,166,167,168,169],"Melanoma, Stage III","Skin","Melanoma, Stage IV","Pembrolizumab","Cyclophosphamide","2026-03-06",{"date":172,"type":32},"2026-03-10",{"date":174,"type":32},"2024-12-23",{"date":176,"type":21},"2028-12",{"name":178,"class":104},"University of California, Irvine",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":130},"100419459","early-phase-1-adjuvant-therapy-based-on-pathologic-response-after-neoadjuvant-encorafenib-binimetinib-in-melanoma-100419459","NCT04741997","Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma","A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* Histologically confirmed diagnosis of melanoma. Any primary or unknown origin is permitted.\n* Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B\u002FC\u002FD) or Stage IV (AJCC 8th edition).\n* ECOG performance status ≤ 2\n* Adequate laboratory parameters as well:\n* a. Hemoglobin ≥ 8 g\u002FdL.\n* b. Platelets ≥ 75 × 109\u002FL;\n* c. AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN;\n* d. Total bilirubin ≤ 1.5 × ULN and \\\u003C 2 mg\u002FdL; OR total bilirubin \\>1.5 × ULN with indirect bilirubin \\\u003C 1.5 × ULN;\n* e. Serum creatinine ≤ 2.0 × ULN\n* Female participants of childbearing potential as described in protocol, must have a negative serum or urine β-HCG test result. Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, as described in Section 4.3.1. Participants must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy. Male participants must agree to use methods of contraception that are highly effective or acceptable per protocol.\n\nExclusion Criteria:\n\n* Participants may have received prior therapy with BRAF and\u002For a MEK inhibitor if it was completed at least 6 months prior to study enrollment. Patients who had prior disease progression while on BRAF\u002FMEK inhibitor therapy are not eligible. (Progression after stopping treatment is permitted.) Participants may have received prior therapy an anti-PD-1\u002FPD-L1 or CTLA-4 inhibitor.\n* Participants must not have had adverse events related to encorafenib and\u002For binimetinib specifically, that required discontinuation of one or both drugs due to toxicity.\n* Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure.\n* Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while they are taking encorafenib\u002Fbinimetinib.\n* Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study drug. Patients with previously treated brain metastases may participate provided they are stable (e.g.,without evidence of progression by radiographic imaging for at least 28 days before the first dose of study treatment and neurologic symptoms have returned to baseline).\n* Impaired cardiovascular function as below:\n* a. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 3);\n* b. presence of uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia\n* c. Baseline QTcF interval ≥ 500 ms.\n* Known history of retinal vein occlusion (RVO)\n* Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in protocol, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.\n* Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization.\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization.\n* Pregnancy or breast feeding.",{"count":187,"type":21},50,[189],"EARLY_PHASE1","The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.",[27,56,192],"BRAF V600 Mutation",[166],"2026-02-26",{"date":196,"type":32},"2026-03-02",{"date":198,"type":32},"2021-05-24",{"date":200,"type":21},"2027-07",{"name":129,"class":104},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":211,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":130},"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":210,"type":21},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.",[58,27,56,94],[215,216,217],"circulating tumor DNA","FDG","ICI","2026-01-15",{"date":220,"type":32},"2026-01-20",{"date":222,"type":32},"2024-01-30",{"date":224,"type":21},"2029-01",{"name":226,"class":104},"University of Wisconsin, Madison",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100555183","long-term-follow-up-of-patients-treated-with-miltenyi-cell-and-gene-therapies-100555183","NCT06508775","Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies","LONGSAFE","Inclusion Criteria:\n\n* Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.\n* Patient has provided informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* No exclusion criteria",{"count":235,"type":21},40,[237],"NA","The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.",[27,240,241,242,243,244,56],"B-cell Non Hodgkin Lymphoma","Pediatric ALL","Childhood Non-Hodgkin Lymphoma","Acute Lymphatic Leukemia","Chronic Lymphatic Leukemia","2025-11-20",{"date":247,"type":32},"2025-11-26",{"date":249,"type":32},"2024-05-05",{"date":251,"type":21},"2040-12-31",{"name":253,"class":39},"Miltenyi Biomedicine GmbH",7,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":130},"100401882","beta-glucans-effect-on-pembrolizumab-immunologic-response-in-stage-iii-iv-melanoma-100401882","NCT04513028","Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma","Inclusion Criteria:\n\n* Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).\n* Must be treatment naïve or have had treatment no less than 6 months prior to enrollment\n* 18 years or older\n* Must be able to take pills\n* ECOG performance status of 0-3\n* Ability to understand and willingness to sign a written informed consent\n* Members of all racial and ethnic groups are eligible for this study\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions attributed to beta-glucan\n* Patients receiving continuous or other ongoing immunosuppressive therapy\n* Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately\n* Patients with mucosal melanoma\n* Patients with concurrent malignancy or recent history thereof",{"count":262,"type":21},30,[237],"The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.",[27,56],"2025-10-28",{"date":268,"type":32},"2025-10-30",{"date":270,"type":32},"2020-11-03",{"date":272,"type":21},"2027-01-15",{"name":274,"class":104},"Kelly McMasters",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":105},"100531837","phase-1-to-evaluate-the-safety-and-efficacy-of-adp-tilil7-in-patients-with-locally-advanced-or-metastatic-melanoma-100531837","NCT06204991","To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma","Phase 1 Study to Evaluate the Safety and Efficacy of TILs Transduced With IL-7 (ADP-TILIL7) in Patients With Locally Advanced or Metastatic Melanoma","ADP-TILIL7","Inclusion Criteria:\n\n* All the criteria listed in the following need to be met before patient inclusion.\n\n  1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).\n  2. Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition.\n  3. Age: 18 - 75 years at time of signed Informed consent.\n  4. ECOG performance status of ≤ 1 (Appendix 2).\n  5. Is fit for tumor resection and has at least one lesion (\\> 1 cm3) available for surgical resection for manufacture of TIL.\n  6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding lesion to be resected).\n  7. LVEF assessment with documented LVEF ≥50% by either TTE (transthoracic echocardiography) or MUGA (multigated acquisition scan).\n  8. Sufficient organ function, including:\n\n     * Absolute neutrophil count (ANC) ≥ 1.500 \u002Fµl\n     * Leucocyte count ≥ lower normal limit\n     * Platelets ≥ 100.000 \u002Fµl and \\\u003C700.000 \u002Fµl\n     * Hemoglobin ≥ 6.0 mmol\u002Fl\n     * eGFR \\> 70 ml\u002Fmin\\*\n     * S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN)\n     * ASAT\u002FALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN)\n     * Alkaline phosphatase ≤ 5 times upper normal limit\n     * Lactate dehydrogenase ≤ 5 times upper normal limit\n     * Sufficient coagulation: APPT\\\u003C40 and INR\\\u003C1.5\n* \\* In selected cases it can be decided to include a patient with an eGFR \\\u003C 70 ml\u002Fmin with the use of a reduced dose of chemotherapy.\n\n  9\\. Signed statement of consent after receiving oral and written study information 10. Willingness to participate in the planned controls and capable of handling toxicities.\n\n  11\\. Subject must receive T-cell therapy as the next therapy following tumor resection, unless bridging therapy is administered:\n  * Bridging therapy is discouraged. However, if in the opinion of the Investigator, the subject requires immediate therapy after tumor resection, the subject may receive bridging therapy for the period during which the subject is awaiting the manufacture of TIL-infusion product. Bridging therapy may be a continuation of the therapy the subject was receiving prior to tumor resection or may be a new therapy.\n  * Following this bridging therapy, the subject must adhere to the mandatory washout periods (exclusion criterion 1) and must continue to have measurable disease prior to receiving T-cell therapy.\n\n    12\\. Age and Reproductive Status:\n  * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test AND must agree to use an effective method of contraception starting at the first dose of chemotherapy for at least 12 months. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods. The following are considered safe methods of contraception:\n* Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch)\n* Intrauterine device\n* Surgical sterilization\n* Surgical sterilization of male partner with verification of no sperm after the procedure\n* Menopause (for more than 12 months) o Male subjects must be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with an WOCBP starting at the first dose of chemotherapy and for 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking.\n\nExclusion Criteria:\n\n* Patients will be excluded if they meet one of the criteria's listed below\n\n  1. Subject has received or plans to receive the following therapy\u002Ftreatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC):\n\n     * Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC\n     * Small molecules\u002FTKI: Washout period 1 week before TR and LDC\n     * Immune therapy (monoclonal AB therapy, CPI and biologics): 2 weeks before TR and LDC\n     * Prior T-cell therapy, including gene therapy using an integrating vector\n     * Corticosteroids at dose equivalent \\> 10 mg prednisone or any other immunosuppressive therapy. 2 weeks before TR and LDC. Note: Use of topical steroids is not an exclusion\n     * Investigational treatment: 4 weeks or 5 half-lives, whichever is shorter before TR and LDC\n     * Radiation to the pelvis and\u002For multiple bones containing ≥ 25% of bone marrow: 4 weeks before TR and LDC\n     * Whole brain radiotherapy or brain stereotactic radiosurgery: 4 weeks before TR and LDC\n     * Radiotherapy to the target lesions: 3 months prior to TIL-infusion. A lesion with unequivocal progression post-radiotherapy may be considered a target lesion.\n  2. A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n  3. Patients with metastatic ocular\u002Fmucosal or other non-cutaneous melanoma. Unknown primary melanoma is eligible.\n  4. Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non-clinically significant toxicities e.g., alopecia, vitiligo).\n\n     Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n  5. Patients who have more than 2 CNS metastases or who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clincal or radiologic CNS progression for at least 2 months.\n  6. The following patients will be excluded because of inability to receive high dose interleukin-2:\n\n     * History of coronary revascularization\n     * Patients with clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, 2o or 3o heart block\n     * Documented FEV-1 less than or equal to 60% predicted value for patients with: A prolonged history of cigarette smoking (greater than 20 pack years), large tumor burden in the lungs or Symptoms of respiratory distress.\n  7. Known hypersensitivity to one of the active drugs or one or more of the excipients.\n  8. Severe medical conditions, such as severe asthma\u002FCOLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.\n  9. Acute\u002Fchronic infection with HIV, hepatitis, syphilis among others.\n  10. Severe allergies or previous anaphylactic reactions.\n  11. Active autoimmune or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible:\n\n      * Immune-mediated AEs secondary to immunotherapy which has resolved to ≤ Grade 1 off steroids;\n      * Hypothyroidism, Type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy;\n      * Disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression;\n      * Other stable immune conditions that do not require prednisone higher than 10 mg\u002Fday or their equivalent dose for other corticosteroid agents may be acceptable with the agreement of the Sponsor.\n  12. Pregnant women and women breastfeeding.\n  13. Subject who, in the opinion of the Investigator, will be unlikely to fully comply with protocol requirements.","75 Years",{"count":285,"type":21},10,[51],"The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement.\n\nParticipants will undergo:\n\n* screening\n* tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks\n* admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses\n* Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET\u002FCT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.",[27,56,58],[290,291,292,293],"adoptive cell therapy","immunetherapy","genemodified tumor infiltrating lymphocytes","IL-7","2025-08-19",{"date":296,"type":32},"2025-08-24",{"date":298,"type":32},"2025-04-01",{"date":300,"type":21},"2028-04-01",{"name":302,"class":104},"Inge Marie Svane",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":329},"100513824","phase-1-a-study-assessing-kb707-for-the-treatment-of-locally-advanced-or-metastatic-solid-tumors-100513824","NCT05970497","A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies","Key Inclusion Criteria:\n\n* Life expectancy \\>12 weeks\n* ECOG performance status of 0 or 1\n* Have measurable disease per RECIST v1.1 at Screening\n* Cohorts 1-4 only: Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy.\n* Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and\n\n  1. Subject has previously failed one prior anti-PD-1\u002FPD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and\n  2. If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor\n* Cohort 5 only: Age 12 years or older at the time of informed consent\n* Cohort 6 only: Age 18 years or older at the time of informed consent\n\nKey Exclusion Criteria:\n\n* Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids\n* The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707\n* Have known history of positive human immunodeficiency virus (HIV 1\u002F2)\n* Cohorts 5 and 6 only:\n\n  1. Subject has a known additional malignancy that is progressing or requires active treatment.\n  2. Subject has uveal\u002Focular melanoma.\n  3. The subject has active brain metastases or leptomeningeal metastases\n  4. Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma\n  5. Prior anti-LAG-3 and\u002For anti-PD-1 therapy was intolerable and required discontinuation of treatment",{"count":311,"type":21},240,[51,24],"KB707-01 is a Phase 1\u002F2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma.\n\nSubjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.",[315,27,56,316],"Cancer","Cutaneous Melanoma",[318,319,320],"Krystal Biotech","cancer","melanoma","2025-05-14",{"date":323,"type":32},"2025-05-18",{"date":325,"type":32},"2023-10-31",{"date":200,"type":21},{"name":328,"class":39},"Krystal Biotech, Inc.",15,{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":339,"studyType":211,"phases":4,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100332246","descriptive-observational-study-on-the-characteristics-of-advanced-and-metastatic-melanoma-in-spain-100332246","NCT03605771","Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain","GEM-1801","Inclusion Criteria:\n\n* Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.\n* Signing the Informed Consent Form (ICF).\n* A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria 1.\n* A patient can only sign one ICF (cannot sign an ICF in two different centres).\n* If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered.\n\nExclusion Criteria:\n\n* Any patient not complying with inclusion criteria.",{"count":338,"type":21},400,"24 Months","This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.",[342,343,344],"Melanoma Stage Iv","Melanoma Stage Iii","Advanced Cancer","2025-04-02",{"date":347,"type":32},"2025-04-04",{"date":349,"type":32},"2018-08-07",{"date":351,"type":21},"2025-12",{"name":353,"class":104},"Grupo Español Multidisciplinar de Melanoma",39,{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":130},"100458574","phase-1-fmt-to-convert-response-to-immunotherapy-100458574","NCT05251389","FMT to Convert Response to Immunotherapy","Conversion of Unresponsiveness to Immunotherapy by Fecal Microbiota Transplantation in Patients With Metastatic Melanoma: a Randomized Phase Ib\u002FIIa Trial","Inclusion Criteria:\n\n* Patients should be 18 years or older\n* Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1\n\n  * In case of stage IV disease, only patients with M1a or M1b disease are eligible.\n* Patients have confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans with a four week interval while on anti-PD-1 treatment, of which the second scan has to be performed within 3 weeks prior to signing informed consent.\n* Patients must have measurable disease per RECIST 1.1 criteria\n* Patients have an ECOG performance status of 0-1 (appendix D)\n* Patients have a life expectancy of \\>3 months\n* Patients have adequate organ function as determined by standard-of-care pre-checkpoint inhibitor infusion lab (including serum ALAT\u002FASAT less than three times the upper limit of normal (ULN); serum creatinine clearance 50ml\u002Fmin or higher; total bilirubin less than or equal to 20 micromol\u002FL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 50 micromol\u002FL)\n* Patients have an LDH level of ≤1 times ULN\n* Patients of both genders must be willing to use a highly effective method of birth control during treatment\n* Patients must be able to understand and sign the Informed Consent document\n\nExclusion Criteria:\n\n* Patients with acral, uveal or mucosal melanoma, or patients with an unknown primary\n* Patients who have received treatment for their melanoma other than anti-PD-1 treatment.\n* Stage IV patients with M1c or M1d disease.\n* Patients with autoimmune diseases: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study (except Hashimoto thyroiditis, vitiligo, history of psoriasis, but no active disease)\n* Patients with any grade 3 or 4 immune-related adverse events still requiring active immunosuppressive medication, apart from endocrinopathies that are stable under hormone replacement therapy. Patients who had developed grade 3-4 immune related toxicity, which has reverted to grade I with immunosuppressive drugs and who are off immunosuppression at least two weeks prior to enrollment are eligible\n* Patients with brain or LM metastasis.\n* Patients with an elevated LDH level\n* Patients that have undergone major gastric\u002Fesophageal\u002Fbowel surgery (like Wipple, subtotal colectomy)\n* Severe food allergy (e.g. nuts, shellfish)\n* Patients with a swallowing disorder or expected bowel passage problems (ileus, fistulas, perforation)\n* Severe dysphagia with incapability of swallowing 2 liters of bowel lavage\n* Patients with a life expectancy of less than three months\n* Patients with severe cardiac or pulmonary comorbidities (per judgement of the investigator)\n* Women who are pregnant or breastfeeding\n* Patients with any active systemic infections, coagulation disorders or other active major medical illnesses\n* Patients with other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years\n* Patients who received treatment with antibiotics in the three months prior to study enrolment, or patients we are expected to receive systemic antibiotics during the course of this study",{"count":210,"type":21},[51,24],"In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients.\n\nThis is a randomized double-blind intervention phase Ib\u002FIIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI.\n\nFollowing randomization, patients will receive vancomycin 250 mg, four times daily for 4 days (day -5 up until day -2), and undergo bowel clearance on day -1 (in total 1L MoviPrep). The FMT, either derived from donor group R (who showed a good response on anti-PD-1 therapy) or donor group NR (who showed progression on anti-PD-1 therapy), will be performed by a gastroenterologist using esophagogastroduodenoscopy. A total amount of 198mL (containing a total of 60 gram feces) will be used for transplantation. Anti-PD-1 treatment will be continued according to the patient's regular treatment schedule. Evaluation of safety and response to treatment will be performed.",[27,56],"2025-03-07",{"date":368,"type":32},"2025-03-10",{"date":370,"type":32},"2022-08-31",{"date":372,"type":21},"2026-08",{"name":374,"class":104},"The Netherlands Cancer Institute",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":130},"100489404","safe-stop-ipilimumab-nivolumab-ipi-nivo-trial-100489404","NCT05652673","Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial","Safe Stop IPI-NIVO Trial: Early Discontinuation of Nivolumab Upon Achieving a (confirmed) Complete or Partial Response in Patients with Irresectable Stage III or Metastatic Melanoma Treated with First-line Ipilimumab-nivolumab","Inclusion Criteria:\n\n* 18 years of age or older\n* Irresectable stage III or metastatic melanoma\n* Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:\n\n  * previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed\n  * in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.\n* Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2\u002F+6) weeks from the start of ipilimumab-nivolumab:\n\n  * for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed at baseline\n  * for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30\n  * in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study.\n* Patients should be included after first CR\u002FPR or first confirmed CR\u002FPR according to RECIST v1.1 30:\n\n  * inclusion should take place no later than 5 weeks after first confirmed CR\u002FPR\n  * in case of SD at first response evaluation, confirmed CR\u002FPR is required for inclusion\n  * planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR\u002FPR or first confirmed CR\u002FPR\n  * no later than 9 months after start of treatment with ipilimumab-nivolumab\n* Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)\n* Participants with previously locally treated brain metastases may participate in case they meet the following criteria:\n\n  * completely asymptomatic brain metastases at inclusion\n  * MRI of brain at baseline and for response evaluation during treatment\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Patients with SD\u002FPD according to RECIST v1.1\n* Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.\n* Presence of symptomatic brain metastases:\n\n  * prior to first-line treatment with ipilimumab-nivolumab, or;\n  * when defined as new or progressive brain metastases at the time of study entry;\n  * brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion.\n\n(provided that the other in- and exclusion criteria are met);\n\n* Presence of leptomeningeal metastases;\n* Systemic chronic steroid therapy (\\>10mg\u002Fday prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":383,"type":21},80,[237],"Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab",[56,27,387,388],"Immunotherapy","Toxicity, Drug","2025-02-26",{"date":391,"type":32},"2025-02-28",{"date":393,"type":32},"2023-02-01",{"date":395,"type":21},"2029-12-01",{"name":397,"class":104},"Erasmus Medical Center",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":211,"phases":4,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":130},"100576062","clinical-and-ultrasound-incidence-of-rheumatologic-immune-related-adverse-events-in-stage-iib-iv-melanoma-patients-100576062","NCT06780397","Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients","Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors","Mel-Immuno-Reu","Inclusion Criteria:\n\n* Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.\n* Signature of the patient consent to the study.\n\nExclusion Criteria:\n\n* Patients aged below 18 years of age.\n* Patients who are unable to express consent to the study.\n* Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.\n* Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)\n* Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.",{"count":407,"type":21},100,"Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.\n\nThe main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.\n\nPatients will:\n\n* receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.\n* undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.",[410,27,56],"Melanoma, Stage II","2025-01-13",{"date":413,"type":32},"2025-01-17",{"date":415,"type":21},"2025-02-01",{"date":417,"type":21},"2028-02-01",{"name":419,"class":104},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":428,"targetDuration":430,"studyType":211,"phases":4,"briefSummary":431,"conditions":432,"keywords":434,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":442,"locationsCount":130},"100511505","versatile-ampification-single-molecule-detection-in-liquid-biopsy-100511505","NCT05940311","Versatile Ampification Single-Molecule Detection in Liquid Biopsy","Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy","VerSiLiB","Inclusion Criteria:\n\n* age: ≥ 18\n* PFS≤2\n* Patients willing to sign an informed consent;\n* Confirmed (cytologically or histologically) cutaneous melanoma diagnosis\n* Confirmed BRAF p. V600E tumor status\n* Eligible for BRAFi\u002FMEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III\u002FIV, high risk).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C8 weeks\n* Other clinical conditions preventing blood drawing compliance, as per physician's choice.",{"count":429,"type":21},20,"3 Years","The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.",[433,163,27,56],"Liquid Biopsy",[435],"BRAFV600E","2024-11-25",{"date":438,"type":32},"2024-11-27",{"date":440,"type":32},"2022-04-27",{"date":121,"type":21},{"name":443,"class":104},"Regina Elena Cancer Institute",{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":130},"100537958","phase-2-study-of-the-efficacy-of-intratumoral-l19il2-or-l19tnf-or-l19il2l19tnf-in-combination-with-pembrolizumab-in-unresectable-melanoma-patients-100537958","NCT06284590","Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2\u002FL19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients","A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2\u002FL19TNF, All in Combination with Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients with Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and with Presence of Injectable Metastases","INTACT\u002FMeRCI","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Be \\> or equal to 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of unresectable metastatic melanoma at stage III B, C, D or IV M1a (AJCC 8th ed.). Patients with Stage IVM1b, M1c and M1d oligometastatic disease \\[up to 10 lesions in aggregate including lung, liver, bone or brain, with or without lymph node involvement\\], are eligible. However, patients with symptomatic or rapidly enlarging\u002Fbleeding brain lesions are excluded. Patients with acral lentiginous melanoma are eligible as well. Detailed information about prior therapies and burden of disease at study entry must be available.\n4. Patients must have confirmed primary resistance to or acquired resistance on treatment with an anti-PD1\u002FL1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: a.) Has received at least 2 doses of an approved anti-PD-1\u002FL1 mAb.\n\n   b.) Has demonstrated disease progression (PD) after PD-1\u002FL1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. c.) Progressive disease has been documented within 12 weeks from the last dose of anti- PD-1\u002FL1 mAb.\n\n   i. Progressive disease is determined according to iRECIST. ii. This determination is made by the investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.\n5. Patients harboring the BRAF mutation who received BRAF\u002FMEK inhibition (or declined BRAF\u002FMEK inhibitors) and received thereafter anti-PD1 therapy showing resistance to such immunotherapy are eligible to the study. Anti-PD1 immunotherapy must be the last therapy received by the patient prior to randomization.\n6. Eligible subjects must have measurable disease (according to RECIST v1.1) as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Eligible subjects must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal metastatic melanoma lesion (≥ 5 mm in longest diameter) or with multiple injectable lesions that in aggregate have a diameter of ≥ 5 mm.\n7. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) b.) A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. WOCBP must be using for the time period indicated highly effective contraception methods. WOCBP and effective contraception methods are defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP).\n8. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n\n   Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor tissue submission can be found in the Procedures Manual).\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n10. Have adequate organ function as defined in the following table. Specimens must be collected within 14 days prior to the start of study treatment.\n11. Be able to provide a core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy at Screening. In addition, participants may provide additional biopsy at Week 18 and at the time of discontinuation due to progression\n12. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (e.g. anti-HBsAg and\u002For anti-HBc Ab) a negative serum HBV-DNA test is also required.\n13. All acute toxic effects (excluding alopecia and vitiligo) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1 or baseline unless otherwise specified above. Note: Participants with ≤Grade β neuropathy may be eligible. Participants with endocrinerelated AEs Grade ≤β requiring treatment or hormone replacement may be eligible. Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n14. Full resolution of checkpoint blockade therapy-related adverse effects (including immunerelated adverse effects) and no treatment for these AEs for at least 4 weeks prior to the time of enrollment.\n15. No history of severe immune related adverse effects from prior given immune checkpoint blockade therapy (CTCAE Grade 4; CTCAE Grade 3 requiring treatment \\>4 weeks).\n16. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration. In addition, male participant must refrain from sperm donation during the treatment period.\n17. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Patients with more than 10 distant melanoma lesions in lung, liver, bone or brain combined. Patients with symptomatic or rapidly enlarging\u002Fbleeding brain lesions are excluded.\n2. Uveal melanoma or mucosal melanoma or melanoma with unknown primary.\n\n   Pregnancy Exclusion\n3. A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Prior\u002FConcomitant Therapy\n4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.\n5. Has received prior systemic anti-cancer therapy including investigational agents or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n6. Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤β weeks of radiotherapy) to non-CNS disease.\n7. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD).\n8. Has had an allogeneic tissue\u002Fsolid organ transplant.\n9. Has received live live or live attenuated vaccines within 30 days prior to the first dose of study treatment and while participating in the study. Note: Killed vaccines are allowed. Note: Any licensed COVID-19 vaccine (including for Emergency use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n   Diagnostic assessments\n10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n11. Has a known additional malignancy that is progressing or has required active treatment within the past two (2) years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \\& T1), second primary melanoma in situ, or carcinoma in situ, that have undergone potentially curative therapy are not excluded.\n12. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n13. Has severe hypersensitivity (≥Grade γ) to pembrolizumab and\u002For any of its excipients, or to (immuno)cytokines IL2, TNF and\u002For any of its excipients\n14. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has an active infection requiring systemic therapy.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n18. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n19. Previous enrolment and randomization in this same study.",{"count":453,"type":21},162,[24],"The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.",[27,56],"2024-10-23",{"date":459,"type":32},"2024-10-26",{"date":461,"type":32},"2024-07-12",{"date":463,"type":21},"2028-07",{"name":465,"class":39},"Philogen S.p.A.",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":211,"phases":4,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100366009","binimetinib-plus-encorafenib-real-life-investigation-of-next-generation-melanoma-treatment-100366009","NCT04045691","Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment","Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA","BERING","Inclusion Criteria:\n\n* Written informed consent of the patient with regard to the pseudonymized documentation as well as the transfer and processing of his\u002Fher data within the study and the ADOREG \\[Cancer Registry of German Working Group of Dermato-Oncology\\] registry (data transfer to ADOREG registry only for patients from German sites);\n* Legally capable male or female patient ≥ 18 years of age (no upper limit);\n* Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC \\[Summary of Product Characteristics\\] and by prescription; this decision was taken prior to and independent from the inclusion into the study;\n* Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;\n* Unresectable advanced or metastatic malignant melanoma with BRAF \\[Rapidly Accelerated Fibrosarcoma isoform B\\] V600 mutation;\n* Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 \\[Cytotoxic T-Lymphocyte Antigen-4\\] and\u002For anti-PD(L)1 \\[Programmed cell Death protein 1\\]) in the unresectable advanced or metastatic setting.\n\nExclusion Criteria:\n\n* Previous treatment with a BRAF- and\u002For MEK \\[Mitogen-Activated Protein\u002FExtracellular-signal Regulated Kinase\\]- inhibitor except for:\n\n  \\-- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended \\> 6 months prior start of Encorafenib\u002FBinimetinib treatment;\n* More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;\n* Any previous chemotherapeutic treatment of the melanoma disease;\n* Presence of any contraindication with regard to the encorafenib-binimetinib-treatment as specified in the corresponding SmPCs;\n* Current or upcoming participation in an interventional clinical trial;\n* Current or upcoming systemic treatment of any other tumor than melanoma;\n* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).",{"count":475,"type":21},750,"BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).",[56,27],[472,479,480],"Encorafenib","Binimetinib","2021-01-15",{"date":483,"type":32},"2021-01-19",{"date":485,"type":32},"2019-10-17",{"date":487,"type":21},"2027-09",{"name":489,"class":39},"Pierre Fabre Pharma GmbH",59]