[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,40,76,102,136,165,188,233,264,283,310,337,361,387,413,446,475,510,533,556,580,614,692,718,746],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100645412","neosent-early-anti-pd-1-therapy-in-high-risk-stage-ii-melanoma-100645412",false,"NCT07680699","NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma","NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And\u002FOr Microsatellitosis: An Ambispective Observational Cohort Study","NEOSENT","Inclusion Criteria:\n\n\\- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.\n\nExclusion Criteria:\n\n* Patients without sufficient clinical or follow-up data.\n* Patients who do not provide informed consent (for prospective cohort).","ALL","18 Years",{"count":21,"type":22},250,"ESTIMATED","OBSERVATIONAL","This is an observational cohort study evaluating clinical and pathological outcomes in patients with high-risk stage II melanoma.\n\nPatients are included after receiving treatment as part of routine clinical practice. Decisions about treatment, including whether to start anti-PD1 therapy before surgery, are made by the treating physician and are not influenced by the study.\n\nThe study compares outcomes between patients who started anti-PD1 therapy before surgery and those treated according to the usual timing in clinical practice.\n\nNo treatments are assigned as part of the study.",[26],"Cutaneous Melanoma","RECRUITING","2026-06-26",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2025-04-23",{"date":35,"type":22},"2027-05",{"name":37,"class":38},"AC Camargo Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":63,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":39},"100590480","research-of-double-positive-circulating-cells-tumor-marker--cd45-in-several-types-of-metastatic-cancers-100590480","NCT06967961","Research of Double-positive Circulating Cells (Tumor Marker \u002F CD45+) in Several Types of Metastatic Cancers","DP-PAN-CANCER","Inclusion Criteria:\n\n* 1\\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors\n* 2\\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet\n* 3\\. Age ≥ 18 years\n* 4\\. Patient affiliated to a French Social Security scheme\n* 5\\. Patient having signed his\u002Fher informed consent prior to inclusion in the study and prior to any specific procedure for the study.\n\nExclusion Criteria:\n\n* 1\\. Patient with localized disease.\n* 2\\. Pregnant or breast-feeding women.\n* 3\\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and\u002For procedures set out in the study protocol.\n* 4\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":48,"type":22},450,"INTERVENTIONAL",[51],"NA","A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.\n\nEach patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.\n\n450 patients will be enrolled in total.",[54,55,56,57,26,58,59,60,61,62],"Urothelial Carcinoma","Renal Cancer","Prostate Adenocarcinoma","Adenocarcinoma of Endometrium","Soft Tissue Sarcoma (STS)","Nonseminomatous Germ Cell Tumor","Seminomatous Germ Cell Tumor","Upper Aerodigestive Tract Carcinoma","Cervical Carcinoma",[64,65,66],"metastatic cancers","Double Positive Circulating cells","liquid biopsy","2026-06-12",{"date":69,"type":31},"2026-06-15",{"date":71,"type":31},"2025-07-23",{"date":73,"type":22},"2029-07-23",{"name":75,"class":38},"Institut Claudius Regaud",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":49,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100428161","phase-1-safety-and-preliminary-efficacy-of-mbs81v270-in-cancer-patients-with-advanced-solid-tumours-100428161","NCT04855435","Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours","A Phase I Multicentre, Open-label, Dose Escalation Study to Determine the Safety and Preliminary Efficacy of MBS8(1V270) Administered Intravenously to Cancer Patients With Advanced Solid Tumours","Stage I Inclusion Criteria\n\n1. Male or female aged ≥18 years.\n2. Diagnosis of a histologically or cytologically confirmed solid tumour that was advanced and with progression. No standard treatment existed, or the participant refused standard treatment. Experimental immunotherapy appeared as a feasible exploratory treatment option as per Investigator's assessment.\n3. Tumour lesion(s) accessible to serial biopsies.\n4. Was willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and tumour biopsies. Mandatory Baseline and on-treatment tumour biopsies were required. However, a biopsy may have been omitted if the procedure was deemed medically unsafe or not feasible, based on the Investigator's clinical judgment and after discussion with the Medical Monitor (or Sponsor's designee).\n5. Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n7. Life expectancy \\>3 months as assessed by the Investigator.\n8. Adequate bone marrow, cardiopulmonary, renal and hepatic functions:\n\n   • Haemoglobin ≥5.6 mmol\u002FL (≥90 g\u002FdL) (without transfusion or erythropoietin therapy within 4 weeks prior to therapy)\n\n   • Neutrophils ≥1.5×109\u002FL, without growth factor stimulation within 3 weeks prior to the blood test\n\n   • Platelet count ≥75×109\u002FL\n\n   • Serum creatinine ≤1.25×ULN or creatinine clearance ≥50 mL\u002Fmin (by CKD-EPI formula)\n\n   • Hepatic function: AST and ALT ≤2.5×ULN; (5×ULN in the case of liver metastases); bilirubin ≤1.5×ULN except in the case of Gilbert's syndrome and 2×ULN in the case of liver metastases.\n9. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have had a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agreed to use highly effective method for contraception according to the European Union (EU) Clinical Trial Facilitation Group guidance from time of signing the informed consent form (ICF) until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must have also applied contraceptive methods and were recommended not to donate sperm.\n10. Ability to understand and sign the ICF.\n\nStage II General Inclusion Criteria The following general inclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Male and female aged ≥18 years.\n2. Eastern Cooperative Oncology Group performance status 0 to 1.\n3. Life expectancy ≥3 months as assessed by the Investigator.\n4. Adequate organ function within 7 to 14 days prior to Day 1. • Absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; haemoglobin ≥9 g\u002FdL (transfusion allowed per site's policy) • Aspartate transaminase\u002FALT ≤3×ULN (≤5×ULN in case of liver metastases)\n\n   • Total bilirubin ≤1.5×ULN (≤3×ULN in case of Gilbert's syndrome)\n   * Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault or measured)\n   * International normalised ratio (INR)\u002Factivated partial thromboplastin time (APTT) within institutional limits (unless on stable anticoagulation).\n5. Prior systemic anti-cancer therapy with a washout period of ≥14 days plus resolution of drug-related AEs before C1D1. Participants should have recovered from prior therapy-related toxicities to Baseline or Grade ≤1 (except alopecia and other non-clinically significant AEs) and meet all Baseline laboratory criteria. Any deviation requires documented approval from the Sponsor\u002FMedical Monitor with justification in the source record.\n6. Major surgery ≥4 weeks, palliative radiotherapy ≥2 weeks, stereotactic body radiation therapy to lung\u002Fliver ≥3 weeks.\n7. No systemic steroids \\>10 mg\u002Fday prednisone-equivalent within 14 days before C1D1.\n\n   Note: Physiologic\u002Freplacement doses (e.g., adrenal insufficiency) up to 10 mg\u002Fday prednisone-equivalent, topical, inhaled, intra-articular, intranasal, or ophthalmic steroids are allowed.\n8. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agree to use highly effective method for contraception according to the EU Clinical Trial Facilitation Group guidance from the time of signing the ICF until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must also apply contraceptive methods and are recommended not to donate sperm.\n9. Ability to provide informed consent and comply with trial procedures.\n10. Lactate dehydrogenase ≤2.0×ULN at Screening (single repeat allowed, if confounded).\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort A. 11A. Histologically\u002Fcytologically confirmed metastatic cutaneous melanoma. 12A. Prior exposure to pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression.\n\n13A. No untreated or unstable brain metastases. Participants with treated\u002Fstable CNS metastasis are eligible if the condition is radiographically stable for ≥4 weeks, no new\u002Fworsening neurologic symptoms, and off steroids or on stable\u002Fdeclining ≤10 mg\u002Fday prednisone-equivalent for ≥14 days.\n\n14A. Last dose of pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab was given ≤12 weeks prior to Screening, and with no other therapy started.\n\n15A. No prior Grade ≥3 irAE leading to permanent discontinuation of prior anti-PD1\u002FPD L1.\n\n16A. Willing to receive pembrolizumab per SmPC\u002Flabel-concordant schedule. Stage II - Cohort B (Uveal Melanoma; MBS8(1V270) Monotherapy) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort B. 11B. Histologically\u002Fcytologically confirmed metastatic uveal (ocular) melanoma. 12B. Prior tebentafusp exposure with subsequent progression.\n\n* With documented SD lasting ≥6 months, or any CR or PR\n* RECIST v1.1 progression on tebentafusp.\n* Washout ≥14 days from the last tebentafusp dose, tebentafusp-related AEs recovered to Grade ≤1\u002FBaseline.\n* No new organ crisis (e.g., hepatic failure risk, spinal cord compromise) in the prior 4 weeks.\n* No escalation of corticosteroids for tumour-related symptoms within 14 days. 13B. Prior exposure to pembrolizumab, nivolumab, or nivolumab + ipilimumab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression, independent of prior tebentafusp therapy.\n\nExclusion Criteria A participant was not eligible for the trial if any of the following applied. Stage I Exclusion Criteria\n\n1. Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea or mitomycin) except for medications with half-lives \\\u003C5.5 days.\n2. Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to the major airways, where tumour necrosis may have caused perforation or severe bleeding episodes. Primary or metastatic intestinal disease in situ where tumour necrosis may have caused gastrointestinal perforation.\n3. Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.\n4. Major surgical procedure within 14 days prior to the first dose of trial treatment.\n5. Had a history of another primary malignancy, except for:\n\n   • Malignancy treated with curative intent and with no known active disease within 2 years prior to the first dose of MBS8(1V270)\n\n   • Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma\n\n   • Adequately treated uterine cervical cancer Stage 1B or less.\n6. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids \\[\\>10 mg prednisone per day or equivalent, except topical or inhaled\\] cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-IL-6 receptor agents, and anti-tumour necrosis factor \\[TNF\\]α agents) within 2 weeks prior to initiation of trial treatment, or anticipation of need for systemic immunosuppressive medication during trial treatment.\n7. Treatment with androgen deprivation therapies such as luteinizing hormone-releasing hormone (LHRH) (gonadotropin-releasing hormone \\[GnRH\\]) agonists within 2 weeks prior to initiation of trial treatment.\n8. Ongoing irAEs and\u002For AEs Grade ≥2 not resolved from previous therapies except vitiligo, resolved atopy, limited psoriasis, stable neuropathy Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.\n9. Had uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, human immunodeficiency virus (HIV), immune dysfunction such as autoimmune disease, psychiatric illness such as depression or suicidal tendency or social situations that would have limited compliance with trial requirements.\n10. Had active or history of immunologic-mediated disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, or Guillain-Barré syndrome.\n11. Had clinically significant cardiac disease, including:\n\n    • Known congestive heart failure Grade III or IV by the New York Heart Failure Association (see Appendix A)\n    * Myocardial infarction within 6 months prior to signing the ICF\n    * Onset of unstable angina within 6 months prior to signing the ICF.\n12. History of severe allergic episodes.\n13. Known hypersensitivity to any component of MBS8(1V270).\n14. Had a history of seizure disorders uncontrolled on medication.\n15. Had a history of clinically significant coagulation or bleeding disorders or abnormalities.\n16. Abnormal or clinically significant coagulation parameters (i.e., INR and APTT) at the discretion of the Investigator.\n\n    Participants treated with anticoagulants were excluded if the coagulation parameters were outside the therapeutic intervals as described in the SmPC for the administered treatment.\n17. Women of childbearing potential who denied remaining abstinent (refrain from heterosexual intercourse) or did not use a highly effective form of contraception that resulted in a failure rate of \\\u003C1% per year during the Treatment period and up to 120 days after the last trial drug administration.\n18. Men of reproductive potential who denied following accepted contraception methods during the Treatment and up to 120 days after the last trial drug administration.\n19. Pregnant or lactating women.\n20. Had a history or current evidence of any condition, therapy, or laboratory abnormality that might have confounded the results of the trial, interfered with the participant's participation for the full duration of the trial, made administration of the trial drugs hazardous, or made it difficult to monitor adverse effects such that it was not in the best interest of the participant to participate, and in the opinion of the treating Investigator.\n21. Had an autoimmune disorder requiring immune-modulating treatment (\\>10 mg prednisone per day or equivalent, except topical or inhaled) during the last 2 years prior to the first dose of MBS8(1V270).\n\nStage II General Exclusion Criteria The following general exclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Uncontrolled intercurrent illness: active infection requiring IV therapy, uncontrolled congestive heart failure, unstable angina, significant arrhythmia, recent myocardial infarction (≤6 months), or uncontrolled hypertension.\n2. Known active HIV with uncontrolled viraemia, active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) with high viral load (HBV \\>20,000 IU\u002FmL and HCV \\>800,000 IU\u002FmL) despite therapy (enrol per local guidelines, if controlled).\n3. Pregnant or breastfeeding.\n4. Second malignancy requiring active therapy (except adequately treated non-melanoma skin cancers, in situ cancers, or malignancies in remission ≥2 years)\n5. Allergy\u002Fhypersensitivity to trial drug components.\n6. Live vaccines within 28 days prior to C1D1.\n7. QTcF \\>500 ms.\n8. Any condition that, in the Investigator's judgement, compromises safety or compliance.\n9. Active autoimmune disease requiring systemic treatment in the past 2 years (topicals\u002Finhaled\u002Fphysiologic replacement allowed).\n10. Any prior exposure to systemic or IT immunotherapy (except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab), but including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, messenger ribonucleic acid -based vaccines, T cell therapy, and oncolytic viruses.\n11. Participants who have been previously treated with experimental anti-cancer vaccines.\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort A. 12A. Prior life-threatening or Grade ≥3 immune-related toxicity to immune checkpoint inhibitors requiring permanent discontinuation of these therapies (exception: controlled endocrinopathies on replacement).\n\n13A. Interstitial lung disease\u002Fpneumonitis (current or history requiring steroids).\n\n14A. Concurrent anti-cancer therapy other than trial-allowed supportive care. 15A. Histologically\u002Fcytologically confirmed cutaneous acral melanoma and mucosal melanoma.\n\nStage II - Cohort B (Uveal Melanoma, MBS8(1V270) Monotherapy) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort B. 12B. Active, uncontrolled hepatic dysfunction not attributable to tumour (e.g., acute hepatitis).\n\n13B. Any contraindication specific to MBS8(1V270) per IB (e.g., known hypersensitivity to excipients, cohort-specific risk factors).\n\n14B. Brain metastases.",{"count":84,"type":22},106,[86],"PHASE1","The Phase I trial is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)",[89,90,26],"Advanced Solid Tumor","Uveal Melanoma, Metastatic","2026-06-09",{"date":93,"type":31},"2026-06-11",{"date":95,"type":31},"2021-04-12",{"date":97,"type":22},"2027-06",{"name":99,"class":100},"MonTa Biosciences ApS","INDUSTRY",5,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":49,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100358462","phase-1-study-of-ide196-in-patients-with-solid-tumors-harboring-gnaq11-mutations-or-prkc-fusions-100358462","NCT03947385","Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","A Phase 1\u002F2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","Inclusion Criteria:\n\n* Patient must be ≥18 years of age and able to provide written informed consent\n* Diagnosis of the following:\n\n  o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed.\n\n  \\- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\\*02:01 positive\\*\\*\\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp.\n\n  \\*\\*\\*To be enrolled in the HLA-A\\*02:01 positive cohort, HLA status must be documented by test results from a CAP\u002FCLIA-certified laboratory.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \\> 3 months\n* Adequate organ function at screening\n* Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential\n\nCrizotinib Combination Additional Inclusion Criteria:\n\n* Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib\n* Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients\n* Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.\n\nExclusion Criteria:\n\n* Previous treatment with a PKC inhibitor\n* Known MSI-H\u002FdMMR tumors who have not previously received immune checkpoint inhibitors\n* Known symptomatic brain metastases\n* Adverse events from prior anti-cancer therapy that have not resolved\n* Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus\n* Active infection requiring ongoing therapy\n* Recent surgery or radiotherapy\n* Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect\n* Females who are pregnant or breastfeeding\n* Impaired cardiac function\n* Treatment with prohibited medications that cannot be discontinued prior to study entry\n* For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin\n\nCrizotinib Combination Additional Exclusion Criteria:\n\n* Prior therapy directly targeting ALK, MET, or ROS1\n* Spinal cord compression\n* History of pneumonitis or interstitial lung disease\n* History of syncope\n* History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment\n\nPK Substudy (optional) with Pravastatin Additional Exclusion Criteria:\n\n* Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1\n* Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin\n* Any contraindication associated to the use of statins or hypersensitivity component of pravastatin\n* Active liver disease\n\nDDI Cocktail Substudy Additional Exclusion Criteria:\n\n* Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.\n* Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit\u002Fgrapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.\n* Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Moderate and strong inhibitors of CYP2A4\u002F5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Intake of strong or moderate inducers of CYP3A4\u002F5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.",{"count":110,"type":22},336,[86,112],"PHASE2","This is a Phase 1\u002F2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ\u002F11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.\n\nPhase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study.\n\nCrizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.\n\nAs of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.",[115,26,116,117],"Metastatic Uveal Melanoma","Colorectal Cancer","Other Solid Tumors",[115,119,120,121,122,123,124,125],"Uveal Melanoma","Protein Kinase C","Ophthalmology","Ocular Oncology","Darovasertib","IDE196","Ocular Melanoma","2026-06-04",{"date":128,"type":31},"2026-06-08",{"date":130,"type":31},"2019-06-28",{"date":132,"type":22},"2027-06-15",{"name":134,"class":100},"IDEAYA Biosciences",15,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":49,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100637599","a-study-on-how-to-safely-guide-surgery-for-melanoma-and-similar-skin-tumors-in-children-using-pathology-and-genetic-information-100637599","NCT07621614","A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information","A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz\u002FSpitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients","Inclusion Criteria:\n\n* Patients ≤ 25 years old\n* Newly diagnosed localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report\n* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy\u002Fexcision of the lesion for which they are enrolling. Note that prior biopsies\u002Fsurgery for other benign melanocytic lesions is permitted\n\nExclusion Criteria:\n\n* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasms are eligible\n* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible\n* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy\u002Fexcision, including re-biopsy, of the lesion\n* Any of the following diagnoses\n\n  * Congenital nevi-associated proliferative nodules\n  * Agminated Spitz nevi\u002Ftumors\n  * Dysplastic nevus\n  * Combined nevus\n  * CRTC1::TRIM11 and\u002For MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)\n* Pre-existing conditions:\n\n  * Solid organ transplant recipients\n  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \\[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","25 Years",{"count":145,"type":22},51,[51],"This clinical trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and\u002For recurrence (coming back after a period of improvement), and atypical and high risk for spread and\u002For recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors.",[149,150,151,152,26,153],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Cutaneous Melanocytic Neoplasm","Cutaneous Spitz Melanocytoma","NOT_YET_RECRUITING","2026-06-03",{"date":157,"type":31},"2026-06-05",{"date":159,"type":22},"2026-08-18",{"date":161,"type":22},"2028-07-31",{"name":163,"class":164},"Children's Oncology Group","NETWORK",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":49,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":39},"100540619","phase-2-clear-me-interception-trial-to-detect-and-clear-molecular-residual-disease-in-patients-with-high-risk-melanoma-100540619","NCT06319196","Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma","Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma","ClearMe","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of screening or age of consent according to law.\n2. Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Must have a life expectancy of at least 12 weeks.\n5. Histologically confirmed cutaneous or mucosal melanoma.\n6. High risk melanoma subjects with disease staging for which adjuvant immunotherapy has been proven to reduce the risk of relapse versus observation (disease stage: 2B, 2C, 3A, 3B, 3C, 3D, 4 fully resected).\n7. Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H\\&E and 10 unstained 5 microns slides). If surgery is going to be performed after signing consent, then tumor FFPE from that surgery is allowed.\n8. Patient is a candidate for definitive treatment: including surgery, and post-operative adjuvant immunotherapy with or without radiation for local control.\n9. No detectable disease via imaging (CT scan, MRI, with or without Positron emission tomography (PET) CT scan). Table 4.1.2-1 : Criteria for adequate organ and Marrow function\n10. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception (see Section 8.1.1 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening to 180 days after the final dose of study treatment. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n11. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male subject to also use a highly effective method of contraception throughout this period, as described in Section 8.1.2. In addition, male subjects must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Diagnosis of uveal melanoma.\n2. Any prior systemic anticancer therapy for melanoma. Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is allowed.\n3. Evidence of metastatic disease at surgical and radiological staging.\n4. History of allogeneic organ transplantation.\n5. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to anti-PD-1 or anti-LAG-3 or any of their excipients.\n6. History of active primary immunodeficiency.\n7. Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], immune related diverticulitis \\[prior diverticulitis in the context of diverticulosis is allowed provided is not active\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\].\n\n   The following are exceptions to this criterion:\n   1. Participants with vitiligo or alopecia\n   2. Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 1 year may be included but only after consultation with the Principal Investigator\n   4. Participants with celiac disease controlled by diet alone\n8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive Hepatitis B virus (HBV) surface antigen \\[HBsAg\\] result), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with well-controlled Human Immunodeficiency Virus (HIV) are allowed.\n9. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of myocardial infarction in the last 4 months or high risk of uncontrolled arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the participant to give written informed consent.\n10. History of another primary malignancy except for:\n\n    1. Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study treatment and of low potential risk for recurrence.\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    3. Adequately treated carcinoma in situ without evidence of disease.\n    4. Participants with a history of prostate cancer (tumor\u002Fnode\u002Fmetastasis stage) of Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the opinion of the investigator are not deemed to require active intervention\n11. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 msecs calculated from three ECGs.\n12. Prior nivolumab or relatlimab therapy.\n13. Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention. The following are exceptions to this criterion (see Section 4.7.1.1):\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)\n14. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants should not receive live vaccine whilst receiving study intervention and up to 30 days after the last dose of study intervention. Should the participants be deemed candidates for the Monkey pox vaccine, the case will need to be discussed with the coordinating Principal Investigator.\n15. Participation in another clinical study with an investigational product administered in the last 28 days prior to randomization or concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n16. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n17. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.\n18. Subjects who are unable to willingly provide consent or are unable to comply with the protocol procedures.",{"count":174,"type":22},54,[112],"Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)\u002Fanti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A\u002F2B\u002F3A\u002F3B\u002F3C\u002F3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study.",[26,178,179],"Melanoma Stage IV","Mucosal Melanoma","2026-06-02",{"date":126,"type":31},{"date":183,"type":22},"2026-08-27",{"date":185,"type":22},"2030-02-15",{"name":187,"class":38},"University Health Network, Toronto",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":49,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":232},"100459823","phase-1-study-of-au-007-a-monoclonal-antibody-that-binds-to-il-2-and-inhibits-il-2r-binding-in-patients-with-unresectable-locally-advanced-or-metastatic-cancer-100459823","NCT05267626","Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer","A Phase 1\u002F2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer","Selected Inclusion Criteria:\n\n* Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and\u002For MRI\n* Part 2 includes but is not limited to:\n* Cutaneous melanoma that is either locally unresectable or metastatic:\n\n  * BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4\n  * BRAF mutation: patients who refused BRAF+MEK inhibitor\n  * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1\u002Fanti-CTLA-4 or anti-PD-1\u002Fanti-LAG-3)\n  * Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)\n  * LDH ≤ 2.5 x ULN\n* NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score \\[TPS\\] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy\n* Part 3: NSCLC as described above\n* Part 4: cutaneous melanoma\n\n  * Unresectable locally advanced or metastatic cutaneous melanoma that has progressed during or following treatment with an anti-PDx (unless ineligible for anti-PDx therapy)\n  * Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor\n  * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1\u002Fanti-CTLA-4 or anti-PD-1\u002Fanti-LAG-3).\n  * Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)\n  * LDH ≤ 2.5 x ULN\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female patients of childbearing potential must be willing to use two forms of contraception throughout the study, starting with Screening through 60 days after the last dose of study drug (or 5 months after the last dose of study drug for patients receiving nivolumab). Abstinence is acceptable if this is the established and the preferred contraception method for the patient\n* Male patients with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after discontinuation of study drug and must not donate sperm during this period. In addition, male patients should have their partners use contraception (as documented for female patients) for the same period of time\n* Patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidism are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapy\n* Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n* No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids ≥ 10 mg prednisone\u002Fday or equivalent)\n* No concurrent leptomeningeal disease or cord compression\n\nExclusion Criteria:\n\n* Patients with a history of known autoimmune disease with exceptions of\n\n  * Vitiligo\n  * Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment\n  * History of Graves' disease in patients now euthyroid for \\> 4 weeks\n  * Hypothyroidism managed by thyroid hormone replacement\n  * Alopecia\n  * Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs\n* Major surgery or traumatic injury within 3 weeks before first dose of AU-007\n* Unhealed wounds from surgery or injury\n* Treatment with \\> 10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within the 7 days prior to the initiation of study drug. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed\n* Prior anti-cancer therapy before the planned start of AU-007 as follows:\n\n  * Not recovered to baseline from toxicity of prior systemic cancer therapy(ies).\n  * Not recovered from toxicity of radiotherapy.\n  * Concurrent use of hormones either to maintain castrate levels of testosterone in patients with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted.\n* Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures).\n* Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose. Patients with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration\n* Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required therapy, with the exception of indolent lymphomas",{"count":196,"type":22},159,[86,112],"This is a first in human, open-label, multi-center Phase 1 \u002F 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.",[89,200,26,201],"Metastatic Cancer","Non-Small Cell Lung Cancer",[203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223],"IL-2 CD25","IL-2Ra","Melanoma","Head and neck squamous cell carcinoma","Urothelial cancer","Gastric Cancer","Gastro-esophageal cancer","CD25","IL-2","NSCLC","Bladder Cancer","Merkel Cell Cancer","Proleukin","Immune Therapy","Immunotherapy","Cutaneous Squamous Cell Cancer","Cytokine","Anti-PD-L1","Non-small cell lung cancer","Clear cell renal cell cancer","imneskibart","2026-05-15",{"date":226,"type":31},"2026-05-18",{"date":228,"type":31},"2022-04-04",{"date":67,"type":22},{"name":231,"class":100},"Aulos Bioscience, Inc.",18,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":49,"phases":241,"briefSummary":242,"conditions":243,"keywords":247,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100640027","phase-1-a-first-in-human-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-kup-101a-in-patients-with-selected-advanced-solid-tumors-100640027","NCT07600476","A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available\n* ECOG Performance status of 0 to 2\n* Adequate hematological, renal, and hepatic organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.\n* Known additional malignancy that is progressing or requires active treatment\n* Diagnosis of immunodeficiency\n* Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years\n* Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.\n* Any kind of leukemia\n* Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation\n* Known active central nervous system metastases and\u002For carcinomatous meningitis\n* Cerebral vascular event within 6 months before Screening\n* Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening\n* High grade ocular disease such as uncontrolled glaucoma",{"count":240,"type":22},21,[86],"The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.",[26,179,244,245,246],"Cutaneous Squamous Cell Carcinoma (CSCC)","Merkel Cell Carcinoma of Skin","Basal Cell Carcinoma of Skin",[248,249,250,251,252,253],"TLR4 agonist","TLR7 agonist","TLR4\u002F7 agonist","skin cancer","innate immunity","immunotherapy","2026-05-13",{"date":256,"type":31},"2026-05-20",{"date":258,"type":22},"2026-04",{"date":260,"type":22},"2028-12",{"name":262,"class":100},"Kupando GmbH",2,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":39},"100422255","quality-of-life-lifestyle-and-psychosocial-factors-in-patients-with-melanoma-100422255","NCT04778449","Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma","Inclusion Criteria:\n\n* Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology\n* Able to read and understand English\n* Willing to complete an online or paper survey",{"count":271,"type":22},5000,"This study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. Knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.",[26],"2026-04-29",{"date":276,"type":31},"2026-05-05",{"date":278,"type":31},"2015-08-26",{"date":280,"type":22},"2026-12-31",{"name":282,"class":38},"M.D. Anderson Cancer Center",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":49,"phases":291,"briefSummary":292,"conditions":293,"keywords":296,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100632897","phase-1-phase-1-study-of-pf-08046033-in-advanced-solid-tumors-100632897","NCT07519655","Phase 1 Study of PF-08046033 in Advanced Solid Tumors","A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.\n2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).\n3. Participants must have measurable disease.\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.\n\nExclusion Criteria:\n\n1. Participants with known clinically active central nervous system (CNS) metastases.\n2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.\n3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.\n4. Untreated clinically significant thromboembolic disease.\n5. Previous exposure to GPNMB-targeted therapy.\n6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.",{"count":21,"type":22},[86],"This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.\n\nThe study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.\n\nThe study has two parts:\n\nIn the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.\n\nOnce a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.\n\nParticipants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.",[294,295,26],"Non-Small-Cell Lung","Esophageal Cancer",[297,298,205,299],"Lung cancer","Esophageal cancer","Antibody drug conjugate","2026-04-20",{"date":302,"type":31},"2026-04-23",{"date":304,"type":31},"2026-04-08",{"date":306,"type":22},"2029-07-14",{"name":308,"class":100},"Pfizer",6,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":49,"phases":319,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100564090","phase-2-a-trial-of-lns8801-with-or-without-pembrolizumab-in-patients-with-refractory-melanoma-100564090","NCT06624644","A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma","A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma","Inclusion Criteria:\n\n* Confirmed unresectable and\u002For metastatic cutaneous melanoma.\n* 2 copies of the fully functional form of GPER protein-coding sequence.\n* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.\n* Able to swallow tablets.\n* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.\n* Received an anti-CTLA-4 and\u002For BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and\u002For BRAF therapy prior to and for this study.\n* Measurable disease.\n* Eastern Cooperative Oncology Group Performance Status of 0 to 1.\n\nExclusion Criteria:\n\n* Blue nevus subtype, mucosal, acral lentiginous, or uveal\u002Focular\u002Fchoroidal Melanoma.\n* Previous anti-cancer or investigational drug\u002Fdevice treatment within 4 weeks of the first dose of study drug.\n* Radiotherapy within 2 weeks of starting study drug.\n* Allogeneic tissue\u002Fsolid organ transplant.\n* Unstable autoimmune or immunodeficiency disease.\n* Other concurrent health issues that would make participation or completion of the study difficult.\n* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":318,"type":22},135,[112,320],"PHASE3","The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.\n\n135 patients will be randomly (like flipping a coin) placed in 3 treatment groups.\n\nIn the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years.\n\nIn the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years.\n\nIn the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab\u002Frelatlimab or nivolumab\u002Fipilimumab) as determined by their treating physician.\n\nHow often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.",[323,324,26,325],"Melanoma (Skin Cancer)","Melanoma Stage IIIB-IV","Unresectable Melanoma",[205],"2026-04-18",{"date":329,"type":31},"2026-04-22",{"date":331,"type":31},"2025-08-06",{"date":333,"type":22},"2031-02",{"name":335,"class":100},"Linnaeus Therapeutics, Inc.",9,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":49,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":39},"100533272","phase-2-emla-topical-cream-for-treatment-of-pain-in-patients-receiving-intra-dermal-technetium-99-injections-for-lymphoscintigraphy-for-skin-cancers-100533272","NCT06223659","EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers","Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers","Inclusion Criteria:\n\n* Biologic males or females\n* 18 - 99 years of age\n* Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic\n* History of adhesive allergy\n* Contraindication to Tc99 injection for sentinel lymph node mapping\n* Incarcerated patients\n* Patients incapable of independently providing consent\n* Mucosal or genital lymphoscintigraphy site\n* Pregnancy\n* Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis\n* Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):\"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason\" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure","99 Years",{"count":346,"type":22},100,[112],"This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.",[26,350,351],"Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","2026-03-07",{"date":354,"type":31},"2026-03-10",{"date":356,"type":31},"2023-12-19",{"date":358,"type":22},"2026-10-31",{"name":360,"class":38},"Ohio State University Comprehensive Cancer Center",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":367,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":39},"100423331","frequency-and-clinical-phenotype-of-bap1-hereditary-predisposition-syndrome-100423331","NCT04792463","Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome","Inclusion Criteria:\n\nPatients who meet any of the following criteria:\n\n1. Personal history of one cancer reported in BAP1 cancer predisposition syndrome and family history of at least two 1st or 2nd degree relatives with cancer reported in hereditary BAP1 cancer predisposition syndrome such as UM, CM, mesothelioma, RCC, cholangiocarcinoma, meningioma and hepatocellular carcinoma.\n2. Any patient with personal history of at least 2 cancers reported in hereditary BAP1 cancer predisposition syndrome.\n3. Any subject (affected or unaffected) with a documented BAP1 pathogenic\u002F likely pathogenic variant.\n4. Any patient with a cancer reported in BAP1 and a germline variant of uncertain significance.\n5. At risk relatives of a patient with documented BAP1 mutation.\n\nExclusion Criteria:\n\n* Study material including consent forms are currently only available in English so non-English speaking subjects are excluding",true,{"count":369,"type":22},500,"This research will have a significant impact on the overall management of those cancer patients and their family members who are at risk for hereditary cancer due to germline inactivation of BAP1. Our study will ultimately facilitate the development of novel screening, prevention and treatment strategies for these individuals with the syndrome. Because the vast majority of UM develop in pre-existing nevi, characterization of individuals at high risk for development of UM will allow closer screening and earlier intervention which would improve the treatment outcome not only for retaining vision but also for overall survival. Similarly in patients with germline BAP1 mutation CM develops in premalignant atypical melanocytic lesions and careful follow up of these patients will improve the outcome of their disease. In addition this study could have impact on the management of patients with personal and\u002For family history of several other cancers reported in patients with germline BAP1 mutation such as mesothelioma, renal cell carcinoma, cholangiocarcinoma, hepatocellular carcinoma, meningioma and basal cell carcinoma.",[119,26,372,373,374,375,376,377],"BAP1 Gene Mutation","Renal Cell Carcinoma","Mesothelioma","Hepatocellular Carcinoma","Cholangiocarcinoma","Meningioma Atypical","2026-03-05",{"date":380,"type":31},"2026-03-09",{"date":382,"type":31},"2015-03-03",{"date":384,"type":22},"2026-07-01",{"name":386,"class":38},"Mohamed Abdel-Rahman",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":49,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":39},"100592941","phase-2-neo-irenie-neoadjuvant-ipilimumab-relatlimab-nivolumab-evaluation-100592941","NCT06999980","Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)","A Phase II, Multicentre, Parallel Group, Open Label, Randomised Clinical Trial of Neoadjuvant Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy","Neo IRENIE","COMMON Inclusion Criteria Applicable to all 3 cohorts\n\nInclusion Criteria:\n\n* 1\\. Written informed consent\n* 2\\. Male or female patients who are at least 18 years of age on the day of signing informed consent.\n* 3\\. Clinically detectable disease, and\u002For RECIST version 1.1 defined disease, and\u002For disease confirmed on PET imaging.\n* 4\\. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely achieved is considered \"resectable\".\n* 5\\. Concurrent primary disease and lymph node metastases acceptable provided completely resectable.\n* 6\\. Up to 3 in-transit metastases are permitted as long as these are fully resectable.\n* 7\\. Tumour that is amenable to a newly obtained core biopsy for performance of the multi-omic predictive biomarker model\n* 8\\. ECOG performance status of 0 to 1.\n* 9\\. Adequate haematological, hepatic, renal and endocrine function\n* 10\\. An anticipated life expectancy of \\>12 months.\n* 11\\. Women of child bearing potential (WOCBP) must agree to avoid pregnancy or breast feeding for the duration of study treatment.\n\nInclusion Criteria - Cohort 1 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. No prior systemic treatment for cutaneous melanoma\n* d. Completion of the multi-omic predictive biomarker model within 14 days (7-10 business days) of planned randomisation.\n\nInclusion Criteria - Cohort 2 only\n\n* a. Histologically confirmed diagnosis of cutaneous melanoma or unknown primary melanoma\n* b. AJCC 8th Ed Stage IIIB, IIIC, IIID cutaneous melanoma\n* c. Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable\n* d. No prior treatment with CTLA-4 or LAG-3 inhibitors.\n\nInclusion Criteria - Cohort 3 only\n\n* a. Histologically confirmed diagnosis of mucosal melanoma\n* b. Any stage of disease provided it is fully resectable\n* c. No prior systemic treatment for mucosal melanoma\n\nCOMMON Exclusion Criteria Applicable to all 3 cohorts\n\n* 1\\. Uveal melanoma\n* 2\\. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab\n* 3\\. No prior systemic therapy, including treatment with prior anti-PD1\u002FL1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2 which will have received anti-PD1 monotherapy only.\n* 4\\. 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 14 days of randomisation. The following are permitted:\n\n  1. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)\n  2. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n  3. Non-absorbed intra-articular steroid injections.\n* 5\\. An active autoimmune disease that has required systemic treatment in the past 12 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). The following are permitted:\n\n  1. Vitiligo\n  2. Type I diabetes mellitus\n  3. Residual autoimmune hypothyroidism on stable hormone replacement\n  4. Resolved childhood asthma or atopy\n  5. Psoriasis not requiring systemic treatment\n  6. Autoimmune conditions which are not expected to recur in the absence of an external trigger.\n* 6\\. A known additional malignancy that is progressing or has required active treatment within the past 3 years. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n\n  1. Basal cell carcinoma of the skin\n  2. Squamous cell carcinoma of the skin\n  3. Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy)\n  4. Prostatic intraepithelial neoplasia\n  5. In situ melanoma\n  6. Atypical melanocytic hyperplasia\n  7. Multiple primary melanomas\n  8. Other malignancies for which the patient has been disease free for 1 year.\n* 7\\. A known CNS metastases and\u002For carcinomatous meningitis\n* 8\\. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.\n* 9\\. Has an active infection requiring systemic therapy.\n* 10\\. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n* 11\\. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* 12\\. Has a known history of active TB (Bacillus Tuberculosis).\n* 13\\. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:\n\n  1. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack within the 6 months prior to consent\n  2. Uncontrolled angina within the 3 months prior to consent\n  3. Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n  4. QTc prolongation \\> 480 ms\n  5. History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc)\n  6. Cardiovascular disease-related requirement for daily supplemental oxygen\n  7. History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)\n  8. Patients with history of myocarditis, regardless of aetiology.\n* 14\\. Patients with a \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n* 15\\. Has a history or current evidence of any condition, therapy, 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* 16\\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* 17\\. Pregnant or breast feeding females\n* 18\\. Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule",{"count":396,"type":22},494,[112],"This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.",[26,179],[401,217,402,403],"Neoadjuvant","Randomised trial","Low Responder","2026-02-18",{"date":406,"type":31},"2026-02-19",{"date":408,"type":31},"2026-02-09",{"date":410,"type":22},"2038-01",{"name":412,"class":38},"Melanoma Institute Australia",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":49,"phases":422,"briefSummary":424,"conditions":425,"keywords":434,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":101},"100539601","early-phase-1-177lu-anti-pd-l1-sdab-in-metastatic-solid-tumors-100539601","NCT06305962","177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors","Phase 0\u002F1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Solid Tumours","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Adult participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed relapsed\u002Frefractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1\u002FPD-L1 inhibitors) or have refused or have no standard of care therapy available that is likely to provide clinical benefit.\n4. Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:\n\n   * If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant may be approached to provide written informed consent to have their tumour tissue undergo IHC testing as determined by a validated test (tumour tissue may be obtained from archived samples or from a freshly obtained biopsy).\n   * Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female participants \\\u003C 50 years old who meet the criteria for post-menopausal status without previous surgical sterilisation should be considered for further investigation with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. All male participants must agree to not donate sperm during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n11. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[magnetic resonance imaging (MRI) or computed tomography (CT) scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-RAD204im,\n    * do not require steroids to treat associated neurological symptoms, and\n    * have no history of leptomeningeal disease or spinal cord compression.\n    * Participants with active brain metastases who have not received brain-directed therapy such as radiotherapy are not eligible to enroll.\n12. For Phase I:\n\n    * Participants must have positive lesion(s) by 177Lu-RAD204im SPECT\u002FCT per central review as described in Image Review Charter, and\n    * Participants without any positive lesion by 177Lu-RAD204im SPECT\u002FCT, e.g. due to poor image quality, may be allowed to enrol on a case-by-case basis at the discretion of the Principal Investigator and in discussion with study Sponsor, provided the participant's tumour is known to express PD-L1.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Creatinine clearance or body surface area (BSA) adjusted estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \\\u003C 60 mL\u002Fmin\n   * Platelet count of \\\u003C 80 × 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL\n   * Haemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN, or \\> 5 × ULN for patients with known liver metastases\n   * Total bilirubin \\> 1.5 × ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 × ULN\n   * For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≥1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible to participate.\n8. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure (see Section 20.6)\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g. complete left bundle branch block, third degree heart block)\n   * Uncontrolled hypertension\n   * Known LVEF \\\u003C 50%\n   * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome.\n9. Participation in any other investigational trial at the time of informed consent signature.\n10. Pregnant or lactating women.\n\n    The following exclusion criteria applies to participants in Phase I:\n11. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr.\n12. 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 immune-mediated AE.\n\n    NOTE: endocrine immune-mediated AEs that are controlled with replacement therapy are allowed.\n13. Has had or is scheduled to have major surgery \\\u003C 28 days prior to the first dose of 177Lu-RAD204tr.Surgical procedures not considered to put participants at higher risk of AEs and\u002For interfere with the integrity of study outcome may be allowed on a case-by-case basis in discussion with the Sponsor.\n14. Positive status for human immunodeficiency virus (HIV).\n15. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.\n16. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.\n17. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.",{"count":421,"type":22},30,[423],"EARLY_PHASE1","This is a Phase 0\u002F1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs\u002F recommended doses of 177Lu-RAD204 for future exploration.\n\nThe study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.",[426,427,428,429,26,430,431,432,433],"PDL1 Gene Mutation","Non Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","TNBC, Triple Negative Breast Cancer","HNSCC","Endometrial Cancer","Mmr Deficiency","MSI-High",[435,427,436,429,26,430,437,432,433],"PDL1 Positive","Small Cell Lung Cancer (SCLC)","Endometrial cancer","2026-02-17",{"date":406,"type":31},{"date":441,"type":31},"2024-06-03",{"date":443,"type":22},"2027-12",{"name":445,"class":100},"Radiopharm Theranostics, Ltd",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":49,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100588809","phase-1-actengine-ima203-combined-with-mrna-4203-100588809","NCT06946225","ACTengine® IMA203 Combined With mRNA-4203","A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)","Inclusion Criteria:\n\n* Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease\n* HLA-A\\*02:01 positive\n* Adequate selected organ function per protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n* Life expectancy more than 5 months\n* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor\n* SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.\n* Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration\n\nOther protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease\n* History of cardiac conditions as per protocol\n* Prior allogenic stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2\n* History of hypersensitivity to mRNA-based medicines\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection\n* Any condition contraindicating leukapheresis\n* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol\n* Participants with active brain metastases prior to lymphodepletion\n* Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment\n* Participants with renal impairment AND reduced bone marrow reserve per protocol\n\nOther protocol defined exclusion criteria could apply",{"count":135,"type":22},[86],"This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).",[26,457],"Synovial Sarcoma",[253,459,460,461,462,463,464],"T-cell therapy","cutaneous melanoma","synovial sarcoma","RNA vaccine","Immatics","Moderna","2026-01-06",{"date":467,"type":31},"2026-01-08",{"date":469,"type":31},"2025-07-25",{"date":471,"type":22},"2029-08",{"name":473,"class":100},"Immatics US, Inc.",4,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":484,"conditions":485,"keywords":487,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":39},"100612265","melanoma-of-the-skin-and-exposure-to-solar-ultraviolet-radiation-at-work-in-modena-territory-a-case-control-study-to-promote-an-active-search-and-prevention-of-occupational-diseases-based-on-recent-inail-criteria-100612265","NCT07251335","Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria","Mesur","Inclusion Criteria:\n\n* Be a patient of the Dermatology Clinic at the University Hospital of Modena.\n* Be 18 years of age or older.\n* Have undergone a dermatological screening for a suspected skin lesion.\n* Be able to understand and sign an informed consent form in italian language.\n\nExclusion Criteria:\n\n* Be under 18 years of age.\n* Have cognitive impairment that prevents providing reliable answers to the interview or recalling past exposures.",{"count":483,"type":22},300,"The goal of this observational study is to learn about the link between work-related sun exposure and a specific type of skin cancer called melanoma in people living in the Modena area, Italy.\n\nThe main questions it aims to answer are:\n\n* Is there a connection between working outdoors and developing types of melanoma that are linked to long-term sun exposure?\n* Can we use recent criteria from the Italian workers' compensation authority (Istituto Nazionale per l'Assicurazione contro gli Infortuni sul Lavoro, INAIL) to better identify and report these melanomas as occupational diseases?\n\nParticipants in this study will:\n\n* Be patients of the Modena University Hospital Dermatology Clinic who are already undergoing a skin biopsy for a suspected lesion.\n* Take part in a one-time interview with a trained healthcare worker.\n\nAnswer questions about their:\n\n* Job history and specific work locations (to calculate local UVR exposure).\n* Sun exposure habits at work and in their free\u002Fholiday time.\n* Use of sun protection (e.g., sunscreen, protective clothing).\n* Use of tanning beds.\n* Natural skin color and tendency to sunburn (and other elements to determine their specific skin phototype).\n* Other personal and family health factors.\n\nResearchers will compare two groups:\n\n* Cases: 120 participants who are diagnosed with melanoma after the biopsy.\n* Controls: 180 participants who screened negative for melanoma but may show another skin condition.\n\nBy comparing these groups, researchers aim at better understanding the role of outdoor work as a risk factor for specific melanoma subtypes. For participants diagnosed with a melanoma that is likely linked to their job, the study team will promote its reporting as an occupational disease.",[486,26],"Skin Melanoma",[488,26,489,490,491,492,493,494,495,496,497,498,499,500],"Skin melanoma","Occupational Exposure","Solar Ultraviolet Radiation","Outdoor Workers","Case-Control Study","Occupational Disease","Skin Cancer","Cumulative Sun Damage","Lentigo Maligna Melanoma","Occupational Health","Dermatology","Italy","Occupational Medicine","2025-12-09",{"date":503,"type":31},"2025-12-18",{"date":505,"type":31},"2025-07-07",{"date":507,"type":22},"2027-11",{"name":509,"class":38},"University of Modena and Reggio Emilia",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":49,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":263},"100531064","phase-1-defactinib-and-avutometinib-with-or-without-encorafenib-for-the-treatment-of-patients-with-brain-metastases-from-cutaneous-melanoma-100531064","NCT06194929","Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma","Phase 1b\u002F2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma","DETERMINE","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent.\n* Provide written informed consent and comply with the study protocol as judged by the Investigator. Of note, If the subject has an impairment that prevents him\u002Fher from providing written consent, the site may follow local institutional procedures for obtaining consent.\n* Histologically confirmed diagnosis of cutaneous melanoma with radiographically confirmed metastases to the brain.\n* Must have a tumor with a known RAS, BRAF, or NF1 mutation or triple wildtype status using validated testing methods prior to enrollment. Cohorts will be assigned as follows:\n\n  * Cohort A: RAS, BRAF, NF1, or triple wildtype\n  * Cohort B: BRAF V600E or BRAF V600K\n* Must have at least 1 untreated (no prior resection or radiation of the target lesion) parenchymal brain metastasis with minimal dimensions of ≥ 0.5 cm diameter and maximal dimensions ≤ 4 cm diameter, measured from a gadolinium enhanced MRI T1 sequence.\n\n  * Note: Subject may have received prior resection or radiation therapy for prior brain metastases.\n* Must have received at least 1 line of prior systemic immunotherapy.\n* For Cohort B, may have received 1 or more lines of prior BRAF or MEK inhibitor therapy.\n* An ECOG Performance Status of 0 or 1, or Karnofsky score \\>= 70\n* Adequate bone marrow, organ function and laboratory parameters:\n\n  * ANC ≥ 1.5 × 109\u002FL;\n  * Hemoglobin ≥ 9 g\u002FdL with or without transfusions;\n  * Platelets ≥100,000\u002Fmm2;\n  * AST and ALT ≤ 2.5 × ULN; in patients with liver metastases ≤ 5 × ULN;\n  * Total bilirubin ≤ 1.5 × ULN; NOTE: Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled\n  * Serum creatinine ≤ 1.5 × ULN; OR calculated creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault formula; OR estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73m2.\n  * International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) as follows:\n\n    * In the absence of therapeutic intent to anticoagulate the patient:\n\n      * INR \\\u003C 1.5 × ULN.\n      * PT \\\u003C 1.5 × ULN.\n      * aPTT \\\u003C 1.5 × ULN.\n      * Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n* For women (any individual assigned female at birth) who are not postmenopausal (ie, \\\u003C 2 years after last menstruation) or surgically sterile (absence of ovaries and\u002For uterus) and who are sexually active, must have a negative serum pregnancy test and agree to use a highly effective method of contraception for the duration of the study and for 90 days following the last dose of study drug.\n* Male patients (any individual assigned male at birth) of reproductive potential must avoid pregnancy in partners who are women of childbearing potential, and such partners should not consider getting pregnant during the study and for at least 90 days after treatment is discontinued or longer if requested by local authorities. Male patients are considered to be of reproductive potential unless permanently sterile by bilateral orchidectomy or vasectomized with appropriate post-vasectomy documentation of absence of sperm in ejaculate.\n* Adequate recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator. Exceptions include alopecia and peripheral neuropathy grade ≤ 2.\n\nExclusion Criteria:\n\n* Receiving other investigational agents.\n* Prior systemic anti-cancer therapy or any investigational therapy ≤ 28 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* Patients with symptomatic brain metastasis, defined as neurologic symptoms with localization attributable to an untreated brain metastases with severity \\>= Grade 2 by CTCAE criteria.\n* History of allergy or hypersensitivity to any of the study treatments or any of their excipients.\n* Inability to swallow and retain study treatment.\n* Uveal or mucosal melanoma.\n* History of or current leptomeningeal metastases.\n* QTcF \\> 450 msec if male and QTcF \\> 470 msec if female.\n* Any hemorrhage or bleeding event that is ≥ Grade 3 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) or Grade 2 intracranial hemorrhage within 4 weeks prior to the start of study treatment.\n* Uncontrolled or severe cardiac disease (eg, history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the last 6 months prior to initiation of study treatment), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia (including atrial flutter\u002Ffibrillation), requirement for inotropic support or use of devices for cardiac conditions (eg, pacemakers\u002Fdefibrillators), or hypertension (patients with systolic blood pressure \\[BP\\] of \\> 160 mm Hg or diastolic BP of \\> 100 mm Hg despite optimal medical management are to be excluded).\n* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.\n* Active, known, or suspected uncontrolled autoimmune disease, which required therapy in the past 2 years, including but not limited to systemic lupus erythematosus, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis.\n* Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Participants on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.\n* Systemic active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* History of bleeding diathesis (irrespective of severity) in the absence of therapeutic anticoagulation.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection.\n* Any condition that could make the patient noncompliant with the study procedures and\u002For study requirements, as judged by the Investigator.\n* Active skin disorder that has required systemic therapy within the past 1 year.\n* History of rhabdomyolysis.\n* Concurrent ocular disorders:\n\n  * Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n  * Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n  * Patients with active or chronic, visually significant corneal disorders, other active ocular conditions requiring ongoing therapy or clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. Examples of visually significant corneal disorders include corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions. Visually significant corneal disorders do NOT include dry eyes, blepharitis, and uncomplicated corneal erosions.\n* Patients with a history of hypersensitivity to any of the active (avutometinib, defactinib, encorafenib) or inactive ingredients of the investigational products.\n* Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy, including:\n\n  * Strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n  * Strong CYP2C9 inhibitors or inducers, due to potential drug-drug interactions with defactinib.\n  * Strong P-glycoprotein (P-gp) inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n  * Strong breast cancer resistance protein (BCRP) inhibitors or inducers, due to potential drug-drug interactions with avutometinib.\n* Concomitant treatment with warfarin. Patients who require anticoagulation but cannot discontinue warfarin must be excluded from the study.\n* Participants taking other prohibited medications in protocol, including anticancer therapy or investigational agents and colony-stimulating factors (CSFs). A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.\n* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and\u002For will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6)\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.",{"count":519,"type":22},33,[86,112],"The goal of this interventional clinical trial is to provide proof-of-principle data for the biologic activity of defactinib in combination with avutometinib in brain metastases from melanoma, and to define the potential role of the combination with mutant BRAF inhibitors or after BRAF\u002FMEK inhibitors in BRAF V600E\u002FK mutant tumors, in individuals with advanced melanoma who experience the development or progression of brain metastases after treatment with immune checkpoint inhibitors.\n\nThe main questions it aims to answer are:\n\n* What is the preliminary response rate of defactinib and avutometinib in patients with RAS mutant, BRAF mutant, NF1 mutant, triple RAS\u002FBRAF\u002FNF1 wild type (wt) melanoma (including RAF fusions)?\n* What is the safety and tolerability of the combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E\u002FK mutant melanoma with at least one untreated brain metastases?\n* What is the preliminary response rate of the three drug combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E\u002FK mutant melanoma.",[26,523],"Brain Metastases","2025-11-25",{"date":526,"type":31},"2025-12-03",{"date":528,"type":31},"2024-03-20",{"date":530,"type":22},"2030-01-15",{"name":532,"class":38},"University of Utah",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":539,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":49,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":39},"100598175","phase-3-a-randomized-phase-iii-study-of-management-of-treatment-naive-primary-melanoma-in-elderly-patients-100598175","NCT07068074","A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients","Inclusion Criteria:\n\n* Patient must be ≥ 75 years of age.\n* Patient must have ECOG Performance Status of 0-2.\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.\n* Patient must be eligible for WLE and SLN biopsy. Patients for whom SLN biopsy would be contraindicated, difficult to perform (i.e., after prior surgery in the draining basin) or impossible (i.e., after prior lymphadenectomy for another cause) are not eligible.\n* Patient must be eligible for surgery and not have uncontrolled medical condition that in the opinion of the medical or surgical oncologist precludes surgical management.\n* Patient must be English or Spanish speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs). Patients who speak only French can be enrolled in Canada and appropriate documents will be made available by the study team.\n\nExclusion Criteria:\n\n* Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.","75 Years",{"count":541,"type":22},428,[320],"Can we treat your melanoma just as effectively without doing a sentinel lymph node (SLN) biopsy in addition to your wide local excision (WLE) procedure? A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well.\n\nWe are doing this study because we want to find out if performing the WLE alone is just as effective as the usual approach for your melanoma, and if it leads to improvements in patients' overall well-being. The usual approach is defined as care most people get for the early stage of melanoma that you currently have.",[26],[537,460,546],"Naive Primary Melanoma in Elderly Patients","2025-11-11",{"date":549,"type":31},"2025-11-13",{"date":551,"type":22},"2025-12-12",{"date":553,"type":22},"2031-01-01",{"name":555,"class":164},"Eastern Cooperative Oncology Group",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":564,"conditions":565,"keywords":569,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":39},"100604340","symptoms-of-immune-checkpoint-inhibitor-therapy-in-cutaneous-melanoma-100604340","NCT07148245","Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma","Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Able to speak and read English\n* Diagnosed with stage IIB, III, or IV cutaneous melanoma\n* Participants who are scheduled to receive \\>=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.\n* Provide written informed consent to participate in this study.\n* Participants with stage IIB or higher cutaneous melanoma\n\nExclusion Criteria:\n\n* Participants will be excluded if they are unable to complete study requirements.",{"count":483,"type":22},"The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.",[26,566,567,568],"Cutaneous Melanoma, Stage III","Cutaneous Melanoma by AJCC V7 Stage","Cutaneous Melanoma, Stage IV",[570],"Toxicity","2025-11-05",{"date":573,"type":31},"2025-11-10",{"date":575,"type":31},"2025-10-13",{"date":577,"type":22},"2027-06-30",{"name":579,"class":38},"University of California, San Francisco",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":613},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825","NCT05059444","ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation","ORACLE","Inclusion Criteria:\n\n* Age \\> 18 years old AND\n* Initial treatment is given with curative\u002Fradical intent AND\n* Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND\n* Provided written informed consent to participate in the study AND\n* Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND\n* Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND\n* Have at least one Landmark blood sample\n\nHave a histologically confirmed Index Cancer that qualifies for inclusion, defined as:\n\nPrimary Study Cohorts\n\n* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),\n* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):\n\nCohort 2A: Resectable OR Cohort 2B: Unresectable,\n\n* Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:\n\nCohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive\u002FHER2-negative invasive breast carcinoma,\n\n* Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,\n* Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),\n* Cohort 6: Gastric adenocarcinoma (stage II-III),\n* Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,\n* Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),\n* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),\n* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),\n* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)\n\nExploratory Cohort\n\n* Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen\n\nExclusion Criteria:\n\n* History of allogeneic organ or tissue transplant\n* Index cancer has predominantly neuroendocrine histology\n* History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral\u002Fmultifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment\n* Known distant metastasis at time of enrollment (with the exception of participants with limited\u002Fresectable stage IV cutaneous melanoma or RCC)",{"count":588,"type":22},2020,"The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.",[591,592,593,594,595,26,596,597,598,599,600,601,602,603,373,604],"Bladder Carcinoma","Ureter Carcinoma","Renal Pelvis Carcinoma","Non-small Cell Lung Cancer","Invasive Breast Carcinoma","Esophageal Carcinoma","Gastroesophageal Junction Carcinoma","Gastric Adenocarcinoma","Pancreatic Adenocarcinoma","Squamous Cell Carcinoma of the Head and Neck","Epithelial Ovarian Carcinoma","Fallopian Tube Carcinoma","Endometrial Carcinoma","Rectal Adenocarcinoma","2025-08-18",{"date":607,"type":31},"2025-08-22",{"date":609,"type":31},"2021-09-07",{"date":471,"type":22},{"name":612,"class":100},"Guardant Health, Inc.",57,{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":49,"phases":624,"briefSummary":625,"conditions":626,"keywords":653,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":691},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":623,"type":22},115,[86,112],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[89,627,628,629,630,631,632,208,633,634,213,350,635,636,637,295,603,638,639,640,641,601,642,643,644,179,26,645,646,647,648,649,650,494,651,652,431],"Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Cervical Cancer","Basal Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Viral Cancer","Cervical Cancers",[211,654,655,656,657,658,659,212,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,253,675,676,677,678,679,680,681],"IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":684,"type":31},"2025-07-09",{"date":686,"type":31},"2021-08-27",{"date":688,"type":22},"2026-12-30",{"name":690,"class":100},"Medicenna Therapeutics, Inc.",27,{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":49,"phases":701,"briefSummary":702,"conditions":703,"keywords":706,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":135},"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":700,"type":22},240,[86,112],"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.",[704,705,178,26],"Cancer","Melanoma Stage III",[707,656,708],"Krystal Biotech","melanoma","2025-05-14",{"date":711,"type":31},"2025-05-18",{"date":713,"type":31},"2023-10-31",{"date":715,"type":22},"2027-07",{"name":717,"class":100},"Krystal Biotech, Inc.",{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":723,"acronym":4,"eligibilityCriteria":724,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":725,"targetDuration":4,"studyType":49,"phases":727,"briefSummary":728,"conditions":729,"keywords":734,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":745},"100490692","phase-1-a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-combination-with-pembrolizumab-in-participants-with-solid-tumor-malignancies-100490692","NCT05669430","A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy\n* Refractory or intolerant to standard therapy(ies)\n* Must have received, be not eligible or decline standard of care therapy\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1\n* Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D\n* Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years\n* Laboratory test results within the required parameters\n* Women of child bearing potential (WOCBP) and men must agree to use adequate contraception\n* Parts B, C and D may include the following tumor types:\n\n  * Endometrial carcinoma\n  * Squamous head and neck carcinoma\n  * Cutaneous melanoma\n  * Non-small cell lung cancer\n  * Proficient MMR (pMMR)\u002FMSS adenocarcinoma of the colon or rectum (Parts C and D only)\n\nParts A, B, C and D Exclusion Criteria:\n\n* Participant with acute leukemia or CLL (Parts A and B only)\n* Participant with heart disease or unstable arrhythmia\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* History of major organ transplant\n* History of a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication\n* Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication\n* Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication\n* Radiation for symptomatic lesions must have been completed prior to the first dose of study medication\n* Participants with liver metastases unless approved by the Sponsor\n* Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1\n* Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)\n* Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and\u002For any of its excipients (Parts C and D only)\n* Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease (Parts C and D only)\n* Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)\n* Active substance abuse",{"count":726,"type":22},365,[86,112],"This is a Phase 1\u002F2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[639,730,731,732,733,26,201],"Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum",[735],"GV20-0251","2025-02-11",{"date":738,"type":31},"2025-02-13",{"date":740,"type":31},"2023-03-23",{"date":742,"type":22},"2027-09-05",{"name":744,"class":100},"GV20 Therapeutics",13,{"id":747,"slug":748,"hasResults":12,"nctId":749,"briefTitle":750,"officialTitle":751,"acronym":4,"eligibilityCriteria":752,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":753,"targetDuration":4,"studyType":49,"phases":755,"briefSummary":756,"conditions":757,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":760,"lastUpdatePostDateStruct":761,"startDateStruct":763,"completionDateStruct":765,"leadSponsor":767,"locationsCount":474},"100523026","phase-1-a-study-of-or502-a-monoclonal-antibody-targeting-lilrb2-alone-and-in-combination-with-anticancer-agents-100523026","NCT06090266","A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents","A Phase 1\u002F2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Informed consent signed by the subject prior to conducting study-specific procedures.\n2. Male or female subjects ≥ 18 years of age.\n3. Histological diagnosis as follows:\n\n   1. Parts A and B (Cohorts A1, A2, and B1): subjects must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy with curative intent.\n   2. Part B (Expansion Cohorts B2-B3): subjects must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced\u002Fmetastatic disease not amenable to local therapy with curative intent.\n4. Prior therapies:\n\n   a. Part A (dose-escalation) and Cohort B1 (monotherapy expansion) i. Subjects must have experienced progressive disease (PD) on an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Subjects must have no available proven curative or life prolonging therapies.\n\n   b. Cohorts B4 and B5 (mini-expansion cohorts) i. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. If subjects have received other lines of immunotherapy, including PD-(L)1-based therapy, they must have demonstrated clinical benefit on each prior immunotherapy. Subjects may also have received additional anti-cancer therapies after failure of a PD-(L)1 inhibitor, but 2nd line subjects are preferred.\n\n   c. Cohorts B2 and B3 (dose-expansion) i. Cohort B2 subjects (CSCC) must have received a PD-(L)1 inhibitor. Subjects may not have received an additional immunotherapy.\n\n   ii. Cohort B3 subjects (PROC) must have received platinum-based therapy and experienced disease progression on or within 6 months of completion of such therapy. Subjects may have received prior anti-PD-1 therapy. Subjects may have received additional therapies after failure of platinum-based therapy.\n5. Subjects must have measurable disease per RECIST v1.1.\n6. People of childbearing potential, if not postmenopausal (defined as no menses for at least 12 continuous months prior to study entry) or surgically sterile, must be willing to practice at least one of the highly effective methods of birth control described in Section 4.3 for at least a menstrual cycle (or partner's menstrual cycle, for male subjects) before and for 4 months after study medication administration.\n7. Resolution of prior clinically significant therapy-related AEs (excluding alopecia and ≤ Grade 2 peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Electrolyte and hormonal supplementation may be used to treat these AEs provided the subject is stable on these supplements.\n8. Minimum of 2 weeks since the last dose of other hormone therapy and 3 weeks since the last dose of other systemic cancer therapy or radiotherapy (\\> 4 weeks in case of nitrosoureas or radio-immuno conjugate therapy). Adjuvant hormonal therapy (e.g., tamoxifen) is allowed provided the original tumor diagnosis was more than 3 years before the first dose of study medication. Subjects with prostate cancer on stable doses of anti-hormone treatment may remain on therapy for this trial.\n9. Subjects must have adequate organ function.\n10. Biopsy specimens:\n\n    1. All subjects must be able to supply an archival tumor tissue specimen. If an archival specimen is not available, subjects may remain eligible with approval of the medical monitor.\n    2. Subjects in Cohort B1 must consent to pre- and on-treatment biopsies. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication.\n    3. Subjects in all other cohorts will be asked to consent to pre- and on-treatment biopsies for biomarker analysis of the acquired tissue. These biopsies are optional and not required for study participation. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication.\n11. Subject is able and willing to comply with the protocol and the restrictions and assessments therein.\n12. As required by local regulations or law, subjects must fulfill the obligation of affiliation or beneficiary of a social security or similar scheme.\n\nExclusion Criteria:\n\n1. Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).\n2. Life expectancy \\\u003C 12 weeks.\n3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \\> 2.\n4. Prior organ or stem cell transplant.\n5. Subjects with symptomatic ascites or pleural effusion. Subjects who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) are eligible.\n6. Subject has a known active central nervous system (CNS) primary tumor or metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg\u002Fday for at least 15 days prior to first dose of study medication. Subjects who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) scan during the screening period.\n7. Subject has a known history of a hematologic malignancy, malignant primary brain tumor, or another malignant primary solid tumor (other than that under study), unless the subject has undergone potentially curative therapy with no evidence of recurrent disease for at least 3 years before the start of treatment.\n\n   1. Subjects with a known history of AJCC Stage 1 cancer that has undergone potentially curative therapy with no evidence of recurrent disease for at least 1 year before the start of treatment may be eligible at the Investigator's discretion after consultation with the Sponsor.\n   2. Subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers at any time before the start of treatment, and have no evidence of recurrent disease, are eligible.\n8. Recent or ongoing serious infection including the following:\n\n   1. Any uncontrolled Grade 3 or higher (per NCI-CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of OR502. Routine antimicrobial prophylaxis is allowed.\n   2. Uncontrolled infection with human immunodeficiency virus (HIV). Subjects 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   3. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Subjects who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for hepatitis B at screening is not required.\n   4. Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction (PCR). Subjects on or having received anti-retroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for hepatitis C at screening is not required.\n   5. Known active or latent tuberculosis (testing at screening is not required).\n9. Autoimmune disease or inflammatory condition requiring systemic anti-inflammatory therapy with exceptions as noted in Exclusion Criterion 10. Subjects on hormone replacement therapy for autoimmune-induced endocrinopathies are eligible.\n10. Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone 10 mg\u002Fday, which are allowed.\n11. QTc interval ≥ 470 msec by electrocardiogram (ECG).\n12. Subject has received an investigational product or been treated with an investigational device within 30 days prior to first administration of study medication.\n13. Subject has received a live vaccine within 30 days prior to first administration of study medication.\n14. For Cohorts A2, B1, B2, and B3 only:\n\n    1. Known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.\n    2. Interstitial lung disease.\n    3. Prior pneumonitis requiring systemic corticosteroid therapy.\n    4. Receiving immunosuppressive therapy, with exceptions as noted in Exclusion Criterion 10.\n    5. A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (\\> 10 mg\u002Fday prednisone or equivalent) for more than 12 weeks.\n15. Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed as outlined in Inclusion Criterion 8.\n16. History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders.\n17. Subjects who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse.\n18. Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.\n19. Vulnerable persons: subjects under judicial safeguard, subjects deprived of their liberty by judicial or administrative decision, subjects under psychiatric care without their consent, subjects admitted to a health or social institution for purposes other than research, adults subject to a measure of legal protection (guardianship or curatorship), and subjects unable to express their consent.",{"count":754,"type":22},168,[86,112],"This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.",[704,758,759,200,89,26,594],"Tumor, Solid","Malignant Neoplasm","2025-01-03",{"date":762,"type":31},"2025-01-07",{"date":764,"type":31},"2023-10-24",{"date":766,"type":22},"2027-02-01",{"name":768,"class":100},"OncoResponse, Inc."]