[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uveal-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uveal-melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,74,102,125,141,177,203,240,264,290,315,341,358,402,424,451,481,509,535,555,581],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100054248","phase-1-a-study-of-ln-144-or-ln-145-in-people-with-advanced-uveal-melanoma-undifferentiated-pleomorphic-sarcoma-dedifferentiated-liposarcoma-or-angiosarcoma-100054248",false,"NCT05607095","A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","Inclusion Criteria:\n\n* Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.\n\n  o Patients will be eligible regardless of the number of prior systemic therapies received.\n* Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* Cohort 3: Must have a confirmed diagnosis of unresectable or metastatic angiosarcoma that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).\n* Patients must be ≥ 18 years of age at the time of consent.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.\n* Patients must have the following hematologic parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL\n  * Platelet ≥ 100,000\u002Fmm\\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period\n* Patients must have adequate organ function:\n\n  * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN\n  * Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n  * Total bilirubin ≤ 2 mg\u002FdL\n  * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg\u002FdL\n* Patients must be seronegative for the following:\n\n  * Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies\n  * Hepatitis B antigen (HBsAg), hepatitis B core antibody (anti- HBc), or hepatitis C antibody (HCV Ab). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n  * Syphilis (Rapid Plasma Reagin \\[RPR\\] test or venereal disease research laboratory \\[VDRL\\] test)\n  * Cytomegalovirus (CMV) IgM antibody titer or PCR assay; and Epstein-Barr virus (EBV) IgM or PCR assay indicating active infection\n  * Herpes simplex virus (HSV)-1 and HSV-2 IgM serology or PCR assay\n* Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen\n* Anyone with prior COVID-19 infection must be asymptomatic for \\>30 days prior to NMA-LD.\n* Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD):\n\n  * Targeted therapy: prior targeted therapy with an EGFR, MEK, BRAF, ALK, ROS1, or other-targeted agents (eg, erlotinib, afatinib, dacomitinib, osimertinib, crizotinib, ceritinib, lorlatinib) is allowed provided the washout is a minimum of 14 days or 5 half-lives (whichever is longer) prior to the start of treatment\n  * Chemotherapy: minimum of 21 days prior to the start of treatment\n  * Immunotherapy: checkpoint-targeted therapy with an anti PD-1\u002Fanti PD-L1, other monoclonal antibodies, or vaccines are allowed, provided the washout is a minimum of 21 days prior to the start of study treatment\n* Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.\n* Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia or vitiligo, prior to enrollment.\n\n  * Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and\u002For had a normal colonoscopy post-immune checkpoint inhibitortreatment, by visual assessment, prior to tumor resection.\n  * Patients with immunotherapy-related endocrinopathies (e.g. hypothyroidism) stable for at least 6 weeks and controlled with hormonal replacement are allowed.\n* Previous surgical procedure(s) is\u002Fare permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.\n* Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:\n\n  * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n* Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.\n\nExclusion Criteria:\n\n* Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Patients who have a history of hypersensitivity to any component or excipient of LN-144\u002FLN-145 or other study drugs:\n\n  * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin®, aldesleukin, IL-2\n  * Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity\n  * Any component of the LN-144\u002FLN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Patients with symptomatic brain metastases (of any size and any number).\n\n  o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.\n* Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.\n* Patients who are pregnant or breastfeeding.\n* Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.\n* Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immunodeficiency syndrome \\[AIDS\\]).\n* Patients who have a left ventricular ejection fraction (LVEF) \\\u003C45% or New York Heart Association (NYHA) functional classification \\> Class 1.\n\n  * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias must have a cardiac stress test.\n  * Patients with any irreversible wall movement abnormalities are excluded.\n* Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:\n\n  * If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.\n  * Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \\\u003C 90%) are excluded.\n* Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.\n* Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.\n* No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.\n\nEligibility Designation for Lymphodepletion\n\nPatients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.\n\nAll patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.\n\nPrior to beginning the NMA-LD preparative regimen the following requirements must be met:\n\n* Patients must meet all eligibility criteria at the time of NMA-LD.\n* Full resolution of any active infection should be documented\n* Critical evaluation of changes in cardiovascular, respiratory, renal, coagulopathy, or immune problems and other major illnesses that may have developed or worsened must be documented\n* Patients with symptomatic, recurrent, pleural effusions that require drainage should not proceed to lymphodepletion without prior placement of a temporary in-dwelling pleural drain\n* All active medical issues must be addressed by Investigator or designee. Re-evaluation with additional imaging or testing may be required\n\nBenefit over risk should be assessed and reassessed throughout the treatment course. Successive lifileucel components (preparative lymphodepleting chemotherapy, LN-144\u002FLN-145 and IL-2 ) should be withheld or discontinued if at any time during the treatment course, at the discretion of the treating physician, benefit may not be justified by risks to the patient\n\nSubsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and\u002For major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.",[26,27,28,29],"Uveal Melanoma","Melanoma","Metastatic Uveal Melanoma","Metastatic Melanoma",[26,27,28,29,31,32,33],"LN-144","22-109","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2022-11-01",{"date":42,"type":20},"2027-05-01",{"name":33,"class":44},"OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100631472","phase-1-neoadjuvant-immunotherapy-for-patients-with-high-risk-eye-melanoma-100631472","NCT07501117","Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma","Neoadjuvant Ipilimumab and Nivolumab for Patients With High-risk Uveal Melanoma","Inclusion Criteria:\n\n* Age ≥ 18 ≤ 80\n* The patient is able to read and understand Danish.\n* Primary, localized and treatment-naive uveal melanoma planned for enucleation (high risk\u002FT3-T4) and available for transvitreal biopsies. The initial diagnosis of uveal melanoma is based on ophthalmologic and clinical findings.\n* ECOG performance status of 0 or 1 (appendix 2)\n* The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin level \\> 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000\u002FmcL, e) Platelets ≥ 75,000 \u002FmcL, f) Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n* Signed statement of consent after receiving oral and written study information\n* Willingness to participate in the planned treatment and follow-up schedule\n* For women of childbearing potential (WOCBP) a negative serum pregnancy test at time of screening and the use of highly effective contraception is required. This applies from screening and until 6 months after treatment.\n\nThe following is considered highly effective methods of contraception: 1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal or transdermal), 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3. Intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5. Bilateral tubal occlusion, 6. Vasectomised partner provided that the vasectomy is confirmed successful, 7. Sexual abstinence defined as refraining from heterosexual intercourse. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods.\n\n\\- Men with female partner of childbearing potential must: 1. Use a condom during sexual intercourse from screening and until 6 months after treatment. 2.\n\nEnsure that their partner uses a highly effective method of contraception (as described above) 3. Agree to refrain from sperm donation, storage, or banking\n\nExclusion criteria\n\n* A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n* Requirement for immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening\n* The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)\n* The patient is pregnant or breastfeeding\n* The patient has an active infection requiring systemic therapy\n* Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.\n* Concurrent treatment with other experimental drugs\n* Any significant active autoimmune disease\n* Severe allergy or anaphylactic reactions earlier in life\n* Known hypersensitivity to one of the active drugs or one or more of the excipients.","80 Years",{"count":55,"type":20},15,[23],"The goal of this clinical trial is to investigate the safety and feasibility of neoadjuvant immunotherapy for patients with high-risk uveal melanoma. The main question is:\n\n\\- Is neoadjuvant treatment with nivolumab and ipilimumab safe and feasible for patientt with high-riks uveal melanoma? In addition pathological response, distant metastases-free survival, overall survival and immunological changes in the tumor microenviroenment after therapy will be assesed.",[26],[60,61,62,63,64],"Immunotherapy","Neoadjuvant therapy","High-risk uveal melanoma","Nivolumab","Ipilimumab","2026-06-29",{"date":67,"type":38},"2026-07-01",{"date":65,"type":38},{"date":70,"type":20},"2029-06-01",{"name":72,"class":44},"Inge Marie Svane",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":55},"100535001","phase-3-adjuvant-tebentafusp-in-high-risk-ocular-melanoma-100535001","NCT06246149","Adjuvant Tebentafusp in High Risk Ocular Melanoma","Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)","ATOM","Inclusion Criteria:\n\n* Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy\n* Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks )\n* High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site.\n* ECOG performance status of 0 or 1\n* 18 years or older\n* HLA-A\\*02:01 positivity by local assessment\n* No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization\n* Adequate organ function\n* Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.\n* For patients of childbearing \u002F reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n* For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.\n* Written informed consent according to ICH\u002FGCP and local regulations\n\nExclusion Criteria:\n\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n* Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment\n* QTcF \\> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)\n* Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to screening\n* Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization\n* Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as \\>200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is not necessary unless clinically indicated.\n* Participant with history of HBV infection will be eligible if on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening.\n* Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.\n* History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible.\n* Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. NOTE: The following exceptions are permitted:\n* Vitiligo\n* Alopecia\n* Managed hypothyroidism (on stable replacement doses)\n* Asymptomatic adrenal insufficiency (on stable replacement doses)\n* Psoriasis\n* Resolved childhood asthma\u002Fatopy\n* Well-controlled asthma\n* Type I diabetes mellitus\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Known contraindication to imaging tracer or any product of contrast media and MRI and\u002For CT contraindications",{"count":83,"type":20},290,[85],"PHASE3","At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.",[26],[89,90,91,92],"Tebentafusp","Adjuvant setting","Randomized phase III study","non-metastatic uveal melanoma",{"date":94,"type":38},"2026-06-30",{"date":96,"type":38},"2024-11-11",{"date":98,"type":20},"2032-11",{"name":100,"class":101},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":73},"100587774","phase-2-adjuvant-quisinostat-in-high-risk-uveal-melanoma-100587774","NCT06932757","Adjuvant Quisinostat in High-Risk Uveal Melanoma","Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma","Inclusion Criteria:\n\n1. Primary diagnosis of uveal melanoma (UM) with a lesion of at least 12 mm in largest basal diameter (LBD) as clinically determined by the treating Investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g., by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.\n2. Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy.\n3. High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX).\n4. No evidence of metastatic disease.\n5. Patients aged \\>18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n7. Life expectancy of greater than 3 months.\n8. Ability to swallow and retain orally administered medication and no clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels.\n9. Adequate organ and marrow function as defined by the local institutional lab and treating physician.\n10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after completion of quisinostat administration. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to study entry.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Additional malignancy that is progressing or requires active treatment. Exceptions include the following cancers: basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, elevated levels of prostate-specific antigen (PSA) stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 2 years or longer.\n2. Any major surgery or extensive radiotherapy except that which is required for definitive treatment of primary UM.\n3. Previous adjuvant treatment for UM after definitive primary tumor therapy.\n4. History of prior Histone Deacetylase (HDAC) inhibitor use.\n5. Patients that cannot be taken off medications that are potent inhibitors of cytochrome (CYP) 3a4\u002FA5 (CYP3a4\u002FA5) and CYP2C9. Inclusion of these patients and of patients on warfarin will require discussion and approval by the Sponsor-Investigator prior to enrollment.\n6. Use of other investigational drugs within 28 days or five half-lives, whichever is shorter, with a minimum of 14 days from the last dose preceding the first dose of study treatment and during the study.\n7. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to quisinostat.\n8. A QT interval corrected for heart rate using the Bazett's formula (QTcB) ≥ 480 msec or history of long QT syndrome.\n9. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection except for patients with cleared HBV and HCV infection demonstrated by undetectable viral levels by polymerase chain reaction (PCR). HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with quisinostat.\n10. Patients with a cardiac ejection fraction outside of the normal range as defined by institutional standards or with a history of clinically significant cardiac arrhythmia as determined by a cardiologist.\n11. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, New York Heart Association (NYHA) Classifications 2-4, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the treating Investigator.\n13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Impaired decision-making capacity.","19 Years",{"count":111,"type":20},63,[113],"PHASE2","The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.",[26],"2026-06-16",{"date":118,"type":38},"2026-06-18",{"date":120,"type":38},"2025-05-27",{"date":122,"type":20},"2030-05-27",{"name":124,"class":44},"University of Miami",{"id":126,"slug":4,"hasResults":11,"nctId":12,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":24,"conditions":133,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":140,"locationsCount":45},"100485901","A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma","A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma","Inclusion Criteria:\n\nCohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.\n\n* Patients will be eligible regardless of the number of prior systemic therapies received.\n\n  * Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy\n* Unresectable disease will be defined by an expert sarcoma surgical onocologist as either (a) low liklihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n* Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n* Patients who refuse standard of care chemotherapy will be eligible\n\n  * One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).\n  * Patients must be ≥ 18 years of age at the time of consent.\n  * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n  * Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.\n  * Patients must have the following hematologic parameters:\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n* Hemoglobin (Hb) ≥ 9.0 g\u002FdL\n* Platelet ≥ 100,000\u002Fmm\\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period\n\n  * Patients must have adequate organ function:\n* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN\n* Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n* Total bilirubin ≤ 2 mg\u002FdL\n* Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg\u002FdL\n\n  * Patients must be seronegative for the following:\n* Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies\n* Hepatitis B antigen (HBsAg), hepatitis B core antibody (anti- HBc), or hepatitis C antibody (HCV Ab). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n* Syphilis (Rapid Plasma Reagin \\[RPR\\] test or venereal disease research laboratory \\[VDRL\\] test)\n* Cytomegalovirus (CMV) IgM antibody titer or PCR assay; and Epstein-Barr virus (EBV) IgM or PCR assay indicating active infection\n* Herpes simplex virus (HSV)-1 and HSV-2 IgM serology or PCR assay\n\n  * Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen\n  * Anyone with prior COVID-19 infection must be asymptomatic for \\>30 days prior to NMA-LD.\n  * Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD):\n* Targeted therapy: prior targeted therapy with an EGFR, MEK, BRAF, ALK, ROS1, or other-targeted agents (eg, erlotinib, afatinib, dacomitinib, osimertinib, crizotinib, ceritinib, lorlatinib) is allowed provided the washout is a minimum of 14 days or 5 half-lives (whichever is longer) prior to the start of treatment\n* Chemotherapy: minimum of 21 days prior to the start of treatment\n* Immunotherapy: checkpoint-targeted therapy with an anti PD-1\u002Fanti PD-L1, other monoclonal antibodies, or vaccines are allowed, provided the washout is a minimum of 21 days prior to the start of study treatment\n\n  * Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.\n  * Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia or vitiligo, prior to enrollment.\n* Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and\u002For had a normal colonoscopy post-immune checkpoint inhibitortreatment, by visual assessment, prior to tumor resection.\n* Patients with immunotherapy-related endocrinopathies (e.g. hypothyroidism) stable for at least 6 weeks and controlled with hormonal replacement are allowed.\n\n  * Previous surgical procedure(s) is\u002Fare permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.\n  * Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:\n* Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal\n* Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomized partner\n* True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n\n  * Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.\n\nExclusion Criteria:\n\n* Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Patients who have a history of hypersensitivity to any component or excipient of LN-144\u002FLN-145 or other study drugs:\n\n  * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin®, aldesleukin, IL-2\n  * Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity\n  * Any component of the LN-144\u002FLN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Patients with symptomatic brain metastases (of any size and any number).\n\n  o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.\n* Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.\n* Patients who are pregnant or breastfeeding.\n* Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.\n* Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immunodeficiency syndrome \\[AIDS\\]).\n* Patients who have a left ventricular ejection fraction (LVEF) \\\u003C45% or New York Heart Association (NYHA) functional classification \\> Class 1.\n\n  * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias must have a cardiac stress test.\n  * Patients with any irreversible wall movement abnormalities are excluded.\n* Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:\n\n  * If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.\n  * Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \\\u003C 90%) are excluded.\n* Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.\n* Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.\n* No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.\n\nEligibility Designation for Lymphodepletion\n\nPatients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.\n\nAll patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.\n\nPrior to beginning the NMA-LD preparative regimen the following requirements must be met:\n\n* Patients must meet all eligibility criteria at the time of NMA-LD.\n* Full resolution of any active infection should be documented\n* Critical evaluation of changes in cardiovascular, respiratory, renal, coagulopathy, or immune problems and other major illnesses that may have developed or worsened must be documented\n* Patients with symptomatic, recurrent, pleural effusions that require drainage should not proceed to lymphodepletion without prior placement of a temporary in-dwelling pleural drain\n* All active medical issues must be addressed by Investigator or designee. Re-evaluation with additional imaging or testing may be required\n\nBenefit over risk should be assessed and reassessed throughout the treatment course. Successive lifileucel components (preparative lymphodepleting chemotherapy, LN-144\u002FLN-145 and IL-2 ) should be withheld or discontinued if at any time during the treatment course, at the discretion of the treating physician, benefit may not be justified by risks to the patient\n\nSubsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and\u002For major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.",{"count":131,"type":20},30,[23],[26,27,28,29],[26,27,28,29,31,32,33],"2026-05-26",{"date":137,"type":38},"2026-05-28",{"date":40,"type":38},{"date":42,"type":20},{"name":33,"class":44},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":176},"100594111","phase-3-neoadjuvant-darovasertib-in-primary-uveal-melanoma-100594111","NCT07015190","Neoadjuvant Darovasertib in Primary Uveal Melanoma","A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)","Inclusion Criteria:\n\n* Primary non-metastatic uveal melanoma\n* Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements\n* ECOG 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Previous treatment for UM\n* Evidence of metastatic UM\n* Attributes that necessitate enucleation regardless of response to therapy\n* Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments\n* Presence of a malignant disease other than the one being treated in this study",{"count":149,"type":20},520,[85],"This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)",[26],[26,154,155,156,157,158,159,160,161,162,27,163,164,165],"Plaque Brachytherapy","Enucleation","Neoadjuvant","Darovasertib","IDE 196","Ocular Melanoma","Choroidal Melanoma","Ophthalmology","Ocular Oncology","Protein Kinase C","GNAQ","GNA11","2026-05-01",{"date":168,"type":38},"2026-05-06",{"date":170,"type":38},"2026-01-25",{"date":172,"type":20},"2031-03",{"name":174,"class":175},"IDEAYA Biosciences","INDUSTRY",94,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":73},"100558404","identification-of-new-candidate-genes-for-hereditary-predisposition-to-uveal-melanoma-100558404","NCT06550674","Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma","IGCMU","Inclusion Criteria:\n\n* Patient with a personal history of uveal melanoma (newly diagnosed, under treatment or in follow-up)\n* Enrolled in or benefiting from a social security scheme\n\nExclusion Criteria:\n\n* Causal pathogenic variation identified in BAP1 or MBD4\n* Patient does not consent to constitutional genetic analysis for diagnostic purposes\n* Patient not consenting to a constitutional genetic analysis for research purposes\n* Pregnant and breast-feeding women\n* Patients under guardianship or trusteeship",{"count":185,"type":20},50,[187],"NA","Only 20% of familial uveal melanomas are explained by a hereditary predisposition, implying the presence of as yet unknown hereditary predispositions. This hypothesis is reinforced by epidemiological studies revealing an excess risk of prostate cancer, thyroid cancer and leukemia in patients who have developed uveal melanoma, even though these cancers are not part of the tumor spectrum of known hereditary predispositions to uveal melanoma (BAP1, MBD4). The identification of new candidate genes, once validated, would enable us to offer these families appropriate surveillance.",[26],[191,192,193],"uveal melanoma","hereditary predisposition","candidate genes identification","2026-03-17",{"date":196,"type":38},"2026-03-19",{"date":198,"type":38},"2024-10-29",{"date":200,"type":20},"2028-04",{"name":202,"class":44},"Centre Jean Perrin",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100371641","phase-1-gene-modified-immune-cells-after-conditioning-regimen-for-the-treatment-of-stage-iiic-or-iv-melanoma-or-metastatic-solid-tumors-100371641","NCT04119024","Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors","Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed malignancy that is considered surgically incurable with either:\n\n  * Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis\n  * Stage IV melanoma including patients with known brain metastases\n  * Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible\n* Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay \\[IHA\\] H-Score \\>= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)\n* Age greater than or equal to 18 years old and less than 75 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* A minimum of one measurable lesion defined as:\n\n  * Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), OR\n  * Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)\n* Absolute neutrophil count (ANC) \\>= 1 x 10\\^9 cells\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Platelets \\>= 75 x 10\\^9\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Hemoglobin \\>= 9.5 g\u002FdL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Aspartate and alanine aminotransferases (AST, ALT) =\\\u003C 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Total bilirubin =\\\u003C 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Creatinine \\\u003C 2 mg\u002FdL (or a glomerular filtration rate \\> 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Patients with melanoma must have progressed following \\>= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent\n* Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis)\n* Must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to purify \\>= 1 x 10\\^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis)\n* Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine\n* Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol\n* Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment\n* Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including patients with primary or secondary adrenal insufficiency who require physiologic replacement with steroids, or patients on inhaled or topical steroids at standard doses\n* Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol\n* A Tiffeneau-Pinelli index \\\u003C 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability\n* Patients will be excluded if they have a history of clinically significant electrocardiography (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) \\\u003C 45% on a cardiac stress test (stress thallium, stress multigated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test)\n* Patients with ECG results of any conduction delays (PR interval \\> 200 ms, corrected QT (QTC) \\> 480 ms), sinus bradycardia (resting heart rate \\\u003C 50 beats per minute), sinus tachycardia (HR \\> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial. Patients with any arrhythmias, including atrial fibrillation\u002Fatrial flutter, excessive ectopy (defined as \\> 20 ventricular premature complex \\[PVC\\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist\n* Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum\u002Furine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study\n* A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study","75 Years",{"count":212,"type":20},18,[23],"This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.",[216,29,217,218,219,220,26,221,222,223,224,225,226,227,228,229,230],"Metastatic Malignant Solid Neoplasm","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Recurrent Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","Acral Melanoma","Neuroendocrine Tumors","Paraganglioma","Pheochromocytoma","Adrenocortical Carcinoma","Pancreatic Neuroendocrine Tumor","Thyroid Cancer","Breast Cancer","Lung Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","2026-03-13",{"date":194,"type":38},{"date":234,"type":38},"2025-10-07",{"date":236,"type":20},"2026-10",{"name":238,"class":44},"Anusha Kalbasi",3,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":73},"100620965","immune-response-to-percutaneous-hepatic-perfusion-with-melphalan-for-ocular-melanoma-metastatic-to-the-liver-100620965","NCT07364474","Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver","Evaluating Immune Response to Percutaneous Hepatic Perfusion With Melphalan for the Treatment of Ocular Melanoma Metastatic to the Liver","Inclusion Criteria:\n\n* Patient has histologically or cytologically confirmed diagnosis of uveal melanoma metastatic to the liver and is determined to be a candidate for percutaneous hepatic perfusion with melphalan\n* The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.\n* Age \\> 18 years at date of informed consent signature having the ability to comply with the protocol.\n* Contrast-enhanced cross-sectional imaging of the abdomen (either CT or MRI) obtained within two months prior to study enrollment\n* Measurable metastatic disease. Subject must have at least one site of metastatic disease ≥ 1 cm in size and amenable to percutaneous image-guided biopsy\n* Life expectancy \\> 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Laboratory requirements:\n* Absolute neutrophil count (ANC) \\> 1 x 109\u002FL\n* Platelets \\> 75 x 109\u002FL\n* Alanine aminotransferase (ALT) \u002F Aspartate aminotransferase (AST) \\\u003C 5 x ULN\n* Total bilirubin \\\u003C3 mg\u002FdL\n* International normalized ratio (INR) \\\u003C1.7\n* Glomerular filtration rate (GFR) \\>30 ml\u002Fmin\n\nExclusion Criteria:\n\n* Lesion to undergo biopsy cannot have undergone prior radiation therapy or other locoregional therapy\n* Continued adverse events from a previously administered chemotherapeutic agents. Grade 1 adverse events and ongoing toxicities such as alopecia are exempt\n* Treatment with systemic corticosteroids exceeding the equivalent of 10 mg\u002Fday of prednisone or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor \\[anti-tumor necrosis factor (TNF)\\] agents) within 2 weeks prior to Day 1, or anticipated requirement for systemic immunosuppressive medications exceeding the equivalent of 10 mg\u002Fday of prednisone during the trial\n* Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of hypersensitivity reactions to contrast agents may be enrolled in the trial.\n* Anticoagulant or anti-platelet medication that cannot be interrupted prior to biopsy\n* Pregnant or lactating\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or that could affect the interpretation of the results or render the patient at high risk from treatment complications.\n* Treatment with systemic immunostimulatory agents (including but not limited to interferon(IFN)s, interleukin \\[IL\\]-2) within 6 weeks or five half- lives of the drug, whichever was shorter, prior to Day 1.\n* Treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, anti-LAG-3 antibodies, within the past three months. Prior treatment with tebentafusp is allowed with no washout period required.\n* Treatment with any investigational systemic medication within at least one month prior to biopsy. If an investigational agent is an immune checkpoint inhibitor, a three-month washout is required. Prior treatment with Darovasertib and Crizotinib is allowed with no washout period required.\n* Signs or symptoms clinically significant of infection within 2 weeks prior to Day 1.",{"count":248,"type":20},10,[187],"This study seeks to better understand the liver's immune response to receiving chemotherapy agent melphalan through Percutaneous Hepatic Perfusion (PHP) for patients with Uveal Melanoma that has metastasized to the liver.",[26],[26,253,254],"Uveal Melanoma, Metastatic","Uveal Melanoma, Metastatic to liver","2026-03-09",{"date":257,"type":38},"2026-03-11",{"date":259,"type":38},"2026-01-27",{"date":261,"type":20},"2028-09",{"name":263,"class":44},"Massachusetts General Hospital",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":270,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":73},"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":272,"type":20},500,"OBSERVATIONAL","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.",[26,276,277,278,279,280,281,282],"Cutaneous Melanoma","BAP1 Gene Mutation","Renal Cell Carcinoma","Mesothelioma","Hepatocellular Carcinoma","Cholangiocarcinoma","Meningioma Atypical","2026-03-05",{"date":255,"type":38},{"date":286,"type":38},"2015-03-03",{"date":67,"type":20},{"name":289,"class":44},"Mohamed Abdel-Rahman",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100516681","phase-3-a-phase-3-randomized-masked-controlled-trial-to-evaluate-efficacy-and-safety-of-belzupacap-sarotalocan-au-011-treatment-compared-to-sham-control-in-subjects-with-primary-indeterminate-lesions-or-small-choroidal-melanoma-100516681","NCT06007690","A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma","CoMpass","Inclusion Criteria:\n\n* Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL\u002FCM)\n* Have no evidence of metastatic disease confirmed by imaging\n* Be treatment naive for IL\u002FCM (subjects who received PDT may be eligible)\n\nExclusion Criteria:\n\n* Have known contraindications or sensitivities to the study drug or laser\n* Active ocular infection or disease",{"count":298,"type":20},100,[85],"The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).",[160,302,26,159],"Indeterminate Lesions",[26,304,159,160],"Eye Cancer","2026-02-26",{"date":307,"type":38},"2026-03-02",{"date":309,"type":38},"2023-12-06",{"date":311,"type":20},"2028-08-15",{"name":313,"class":175},"Aura Biosciences",71,{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":239},"100521470","phase-2-tebentafusp-in-hla-a0201-positive-previously-untreated-metastatic-uveal-melanoma-100521470","NCT06070012","Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma","Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)","Inclusion Criteria:\n\nHistologically or cytologically confirmed untreated metastatic uveal melanoma (mUM).\n\nHLA-A\\*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review.\n\n* If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\\*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method.\n* If the patient is known to be HLA-A\\*0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator prior to enrollment.\n* The following HLA testing methodologies are suitable to determine HLA-A\\*0201 positivity:\n\n  * Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.\n  * HLA testing as part of peripheral blood molecular profiling technology including but not limited to Caris Life Sciences Molecular Profiling Technology.\n* Patients be willing to undergo ctDNA assessment using Signatera assay.\n* Have provided newly obtained core biopsy of a tumor lesion not previously irradiated.\n* Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1\n* Must meet the following criteria related to prior treatment:\n\n  * No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy.\n\n    * NOTE: Patients must be tebentafusp naïve.\n    * NOTE: Patients must not have received prior PD-1, CTLA-4, LAG-3 directed Immune Checkpoint Inhibitor therapy delivered in the adjuvant, and\u002For neoadjuvant settings unless such therapy was received \\>6 months prior initial diagnosis of mUM.\n  * No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization.\n  * Prior surgical resection of oligometastatic disease is allowed.\n  * Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.\n* Life expectancy of \\>6 months as estimated by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening.\n* Patients have measurable disease according to RECIST v.1.1.\n* All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n  * Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment.\n  * QTcF \\> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.\n\n    * NOTE: If the initial automated QTcF interval is \\> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.\n    * NOTE: Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to Screening.\n* Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1.\n* Presence of active brain metastases.\n\n  * NOTE: Patients with brain metastases are eligible if all lesions have been treated surgically and\u002For radiosurgically and there is no evidence of progression for at least 2 weeks by MRI prior to the first dose of study drug.\n  * NOTE: Patients with any evidence of leptomeningeal disease are excluded.\n* Active infection requiring systemic antibiotic therapy.\n\n  • NOTE: Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug.\n* Known history of uncontrolled active human immunodeficiency virus (HIV), hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection.\n\n  * NOTE: Testing for HIV, HBV and\u002For HCV is not necessary unless clinically indicated or the patient has a history of HBV\u002FHCV and\u002For HIV infection.\n  * NOTE: Patients with curatively treated HBV and\u002For HCV infection may be enrolled. In these instances, HBV (quantitative HBV DNA) and\u002For HCV (quantitative HCV RNA) resolution must be documented using a quantitative viral load assay.\n  * NOTE: Patients with HIV who are stably controlled on highly active antiretroviral therapy (HAART) therapy with a low HIV viral load may be enrolled. In these instances, stable control is defined as HAART compliant with a CD4 count of ≥200 cells\u002FμL, and low viral load is defined as \\\u003C200 copies\u002FmL on tests done during Screening.\n* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following:\n\n  * Completely resected carcinoma in situ of any type, resected basal cell and squamous cell carcinomas.\n  * Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment;\n  * Any malignancy considered to be indolent that has never required therapy Sponsor-Investigator evaluation.\n* Any medical condition that would, in the judgment of the Sponsor-Investigator, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.\n* Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment.\n\nNOTE: Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable.\n\n* History of symptomatic autoimmune disease including:\n\n  * Interstitial lung disease.\n  * Pneumonitis requiring corticosteroid treatment or current pneumonitis.\n  * Colitis or inflammatory bowel disease. NOTE: However, patients with a history of autoimmune disease who are currently on physiologic hormone repletion (prednisone or equivalent of 10mg or less) and are otherwise asymptomatic may be enrolled.\n* Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary).\n* Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass.\n* Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent.\n* Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n* Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician.\n* Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug.\n* Receipt of live or attenuated vaccinations 2 weeks prior to starting study therapy. Patients may receive vaccinations on treatment.",{"count":323,"type":20},44,[113],"This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.",[26],[328,329,330,331],"CD8+ TILs","tumor-associated macrophages (TAMs)","PD-L1 (B7- H1)","PD-L2 (B7-DC)","2026-02-25",{"date":334,"type":38},"2026-02-27",{"date":336,"type":38},"2025-08-18",{"date":338,"type":20},"2030-09-30",{"name":340,"class":44},"Diwakar Davar",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":73},"100625369","choroidal-melanoma-patient-reported-outcome-study-cm-pro-in-a-subset-of-au-011-301-compass-subjects-100625369","NCT07421739","Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects","Inclusion Criteria:\n\n* Have enrolled in the Aura-sponsored clinical trial AU-011-301.\n* Access to a connected device (i.e., smartphone, laptop, or tablet)\n\nExclusion Criteria:\n\n* None",{"count":55,"type":20},"To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.",[160,302,26,159],[26,304,159,160],"2026-02-17",{"date":353,"type":38},"2026-02-19",{"date":355,"type":38},"2025-11-12",{"date":311,"type":20},{"name":313,"class":175},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":375,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100578017","phase-1-a-study-of-the-c-kit-specific-antibody-drug-conjugate-nn3201-for-advanced-andor-metastatic-solid-tumors-known-to-express-c-kit-100578017","NCT06805825","A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","Key Inclusion Criteria:\n\nSubjects must meet the following criteria to be eligible for enrollment into the study:\n\n1. Histologically or cytologically confirmed locally advanced, metastatic, and\u002For unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.\n2. Subjects must have received the following treatment:\n\n   Part A (Dose Escalation):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib)\n\n   or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET ChRCC or ccRCC)\n\n   Part B (Dose Expansion):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or\n\n   iii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or ChRCC or ccRCC).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.\n5. Age ≥ 18 years.\n6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).\n7. Adequate heart function as measured by ECHO\u002FMUGA scan.\n8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:\n\n   1. Cytotoxic chemotherapy - At least 21 days\n   2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n   3. Nitrosoureas - At least 6 weeks\n   4. Monoclonal antibody(ies) - At least 28 days\n   5. Radiotherapy - At least 14 days from local site radiation therapy\n9. Negative Serum\u002Furine pregnancy test (for subjects of childbearing potential)\n10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.\n11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.\n\nKey Exclusion Criteria:\n\n1. Has received prior therapy with a c-Kit agent (except GIST subjects).\n2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n3. A condition requiring systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs (inhaled corticosteroids are allowed).\n4. Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at Study Entry, Day -2 to Cycle 1 Day 1.\n5. Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).\n6. Significant cardiovascular impairment.\n7. Significant screening electrocardiogram (ECG) abnormalities.\n8. Known active and clinically significant bacterial, fungal, or viral infection.\n9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg, despite optimal medical management.\n10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.\n11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and\u002For any identified active COVID-19 infection.\n12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.\n13. People who are pregnant or breastfeeding.\n\nOther inclusion and exclusion criteria must also be met to be eligible to participate in this study.",{"count":366,"type":20},67,[23],"This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and\u002For metastatic solid tumors known to express c-Kit.",[370,371,372,26,222,373,374],"Gastrointestinal Stromal Tumors","Small-cell Lung Cancer","Adenoid Cystic Carcinoma","Chromophobe Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma",[376,377,378,379,380,381,382,383,384,370,371,372,26,385,373,374,386,387,388,389,390,391],"GIST","SCLC","ACC","NET","ChRCC","ccRCC","Novelty Nobility","cKit","c-kit","Neuroendicrine Tumors","advanced GIST","advanced SCLC","advanced ACC","advanced NET","advanced ChRCC","advanced ccRCC","2025-09-18",{"date":394,"type":38},"2025-09-23",{"date":396,"type":38},"2025-02-03",{"date":398,"type":20},"2027-12-31",{"name":400,"class":175},"Novelty Nobility, Inc.",5,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":73},"100395103","follow-up-of-patients-with-uveal-melanoma-adapted-to-the-risk-of-relapse-salome-100395103","NCT04424719","Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)","SALOME","Inclusion Criteria:\n\n1. Patient aged of 18 years or more.\n2. Patient with uveal melanoma with high metastatic relapse risk defined as :\n\n   * T2b\u002Fc\u002Fd ou ≥ T3,\n   * or chromosom 3 or chromosom 8 abnormality by CGH array.\n3. Completion of treatment of the primary tumor ≤ 2 months.\n4. Patient able to comply with the schedule of visits and blood samples of the study.\n5. Signed informed consent form or legal representative.\n\nExclusion Criteria:\n\n1. Patient without french social insurance.\n2. Any social, medical or psychological condition making the research process impossible.",{"count":410,"type":20},700,[187],"Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.",[26],[191],"2025-09-02",{"date":417,"type":38},"2025-09-03",{"date":419,"type":38},"2020-07-08",{"date":421,"type":20},"2037-07-07",{"name":423,"class":44},"Institut Curie",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":45},"100597852","phase-1-adding-il-2-to-tebentafusp-to-eradicate-cancer-progression-100597852","NCT07063875","Adding IL-2 to Tebentafusp to Eradicate Cancer Progression","Supplementing With IL-2 to Verifiably eRadicate Radiological Progression","SILVER","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n2. HLA-A\\*02:01 positive\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n4. RECIST 1.1 defined progression on single-agent Tebentafusp, with no other intervening systemic therapies\n\nExclusion Criteria:\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. (NOTE: Participants with treated CNS lesions may enroll provided all of the following apply: Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and\u002For radiation). Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry, AND Greater than 14 days elapsed between the last dose of previous Tebentafusp and first dose of IL-2 on trial)\n2. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions: Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent; Local steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n3. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n4. Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.",{"count":433,"type":20},8,[23,113],"A recent clinical trial found that after 36 months, patients taking tebentafusp had a median survival of 21.6 months, compared to 16.9 months for those in the control group. Since recruitment for tebentafusp in metastatic uveal melanoma (mUM) has ended, a new trial is starting to test whether adding IL-2 can help overcome resistance to tebentafusp and improve its effectiveness.\n\nThis study aims to answer:\n\n1. Can combining tebentafusp with IL-2 improve tumor response and overall survival?\n2. What are the benefits and side effects of this combination therapy?\n\nAll participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. The dosing schedule is as follows:\n\nCycle1:\n\nDay1-3 IL-2 Day4 Tebentafusp Day 10 IL-2 Day 11 Tebentafusp Day 17 IL-2 Day 18 Tebentafusp Day 24 IL-2 Day 25 Tebentafusp\n\nCycle 2 \\& thereafter Day 1 IL-2 Day 2 Tebentafusp Day 8 IL-2 Day 9 Tebentafusp Day 15 IL-2 Day 16 Tebentafusp Day 22 IL-2 Day 23 Tebentafusp",[26,28,437],"Metastatic Uveal Melanoma in the Liver",[439,60,440,441],"metastatic uveal melanoma","Treatment resistance","Combinational immunotherapy","2025-07-02",{"date":444,"type":38},"2025-07-14",{"date":446,"type":38},"2025-06-01",{"date":448,"type":20},"2027-09",{"name":450,"class":44},"St Vincent's Hospital, Sydney",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":73},"100477894","phase-3-adjuvant-melatonin-for-uveal-melanoma-100477894","NCT05502900","Adjuvant Melatonin for Uveal Melanoma","Adjuvant Melatonin for Uveal Melanoma: A Randomized Open Phase III Study","AMUM","Inclusion Criteria:\n\n1. The patient is ≥18 years\n2. The patient has given his\u002Fher written informed consent to participate in the trial.\n3. The patient has a melanoma originating in the choroid or in the ciliary body, as diagnosed by clinical methods and\u002For histological examination.\n\n   AND at least one of the following 7 items:\n4. The patient's tumor is of size category T3d or higher, or stage IIIB or IIIC according to the American Joint Committee on Cancer (AJCC, version 8) criteria.\n5. The patient's tumor is large according to modified criteria from the Collaborative Ocular Melanoma Study (COMS), i.e. largest basal diameter \\>16 mm or apical thickness \\>8 mm.\n6. The patient's tumor was of size category T2a before plaque brachytherapy and has then recurred.\n7. The patient's tumor has an epithelioid cell type (\\>5 epithelioid cells per high power field and \\>90 % of tumor cells epithelioid).\n8. The patient's tumor has a low immunohistochemical expression of BAP1.\n9. The patient's tumor has more than 9 mitoses per high power field.\n10. The patient has \\>60 % risk of metastases within 5 years, as determined with another published and validated prognostic test (e.g. gene expression class 2).\n11. If the patient is already being treated with Melatonin, a two-week wash out period will be applied before randomization.\n\nExclusion Criteria:\n\n1. Oversensitivity or allergy to Melatonin or any of the excipients in the tablet.\n2. The patient has metastatic disease, detectable with radiological examinations or any other method (development of metastases after recruitment to the trial does not disqualify the patient from participation).\n3. The patient is unable to provide informed consent.\n4. The patient has decreased liver function (e.g., liver cirrhosis or hepatitis)\n5. The patient is pregnant or a fertile woman (Women of child-bearing potential, WOCBP). Fertility is defined as the time between menarche and menopause for women that are not permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. Menopause is defined as absence of menstruation for 12 months or longer without other cause.\n6. The patient is breast feeding or is planning to breastfeed before the end of the trial. Women that are included in the trial and begin to breastfeed before the end of the trial must resign from the trial.\n7. The patient has epilepsy.\n8. The patient is being treated (for more than 4 weeks) with CYP1A2 inhibitors Fluvoxamine, Ciprofloxacin, Norfloxacin, or Verapamil, with combined hormonal contraception (containing etinylestradiole and progestin), with hormonal substitution therapy, with 5- or 8-metoxypsoralene or cimetidine. If a patient starts using any of these substances for more than 4 weeks after recruitment to the trial, he or she does not need to resign from the trial but may pause the use of Melatonin, and then restart after the use of the other substance has ceased. Concurrent treatment with CYP1A2 inducers including carbamazepine, fenytoine, rifampicin, omeprazole, calcium antagonists, benzodiazepine-related hypnotics, non-steroid anti-inflammatory drugs (NSAIDs) and beta blockers is not an exclusion criterium. Concurrent treatment with warfarin or other vitamin K antagonists is not an exclusion criterium, but requires information to the patient and discussion about dose adjustments with the prescribing physician.\n9. The primary UM was diagnosed more than 12 months ago.",{"count":298,"type":20},[85],"Uveal melanoma (UM) is the most common type of cancer inside the eyes of adults. Almost half of all patients diagnosed with UM will eventually develop metastases. Once metastases occur, the median patient survival is short.\n\nIn this trial, we will test if treatment with Melatonin after primary tumor diagnosis can prevent or delay the development of metastases. 100 patients diagnosed with primary UM will be randomized to either treatment with Melatonin tablets (20 mg at night), or to a control group. Both groups will be followed for 5 years. At 5 years, the number of patients that have developed metastases in the Melatonin and control groups will be compared (primary outcome measure).",[26,463,464],"Uveal Melanoma, Posterior, Medium\u002FLarge Size","Eye Cancer, Intraocular Melanoma",[466,467,468,469,470,471],"Melatonin","Adjuvant","Preventive","Uveal melanoma","Survival","Phase 3 trial","2025-05-12",{"date":474,"type":38},"2025-05-15",{"date":476,"type":38},"2022-10-02",{"date":478,"type":20},"2031-01-01",{"name":480,"class":44},"Gustav Stalhammar",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":508},"100555990","phase-3-php-in-combination-with-ipi1nivo3-compared-to-ipi3nivo1-only-in-patients-with-uveal-melanoma-liver-metastases-100555990","NCT06519266","PHP in Combination With IPI1\u002FNIVO3 Compared to IPI3\u002FNIVO1 Only in Patients With Uveal Melanoma Liver Metastases","A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination With Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients With Uveal Melanoma Liver Metastases","SCANDIUM-III","Inclusion Criteria:\n\n1. Patient is ≥18 years.\n2. Signed informed consent.\n3. ECOG performance status of 0 or 1.\n4. Histologically or cytologically confirmed liver metastasis of uveal melanoma.\n5. Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver.\n6. No previous treatment for uveal melanoma metastases, except patients that have confirmed progression on tebentafusp, or after surgical resection or ablative treatments (e.g., radiofrequency ablation or stereotactic body radiation therapy).\n7. Patient deemed suitable for percutaneous hepatic perfusion.\n8. Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n9. Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n10. Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nExclusion Criteria:\n\n1. Life expectancy of less than 6 months.\n2. More than 50% of the liver volume replaced by tumor as measured by CT.\n3. Extrahepatic disease as measured by CT of thorax and abdomen.\n4. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.\n5. History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.\n6. Patients who are unable to undergo general anesthesia for any reason.\n7. Reduced renal function defined as S-Creatinine \\>=1.5xULN or Creatinine Clearance \\\u003C 40 mL\u002Fmin, calculated using the Cockroft and Gault formula.\n8. Reduced hepatic function (defined as AST, ALT, bilirubin\\>2.5\\*ULN and PK-INR\\>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology.\n9. Hemoglobin \\\u003C90 g\u002FL or platelets \\\u003C100x109\u002FL or neutrophils \\\u003C1.5x109\u002FL.\n10. Use of live vaccines four weeks before or after the last study treatment.\n11. History of severe reactions to monoclonal antibodies, melphalan, heparin or iodine contrast.\n12. Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.\n13. Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.\n14. A condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n15. Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.\n16. Has a known additional malignancy that is progressing or requires active treatment.\n17. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.\n18. 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.",{"count":19,"type":20},[85],"Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. These metastases are generally refractory to systemic chemotherapy and the median survival for patients with liver metastases is about 6 months. Regardless of treatment, the mortality rate is approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.\n\nThe primary objective with this study is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion (PHP) in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only. Secondary objectives include further efficacy and safety analysis, as well as biomarker discovery.",[26,493],"Liver Metastases",[495,60,26,496,497],"Percutaneous Hepatic Perfusion","Liver metastases","SCANDIUM III trial","2024-11-21",{"date":500,"type":38},"2024-11-25",{"date":502,"type":38},"2024-06-10",{"date":504,"type":20},"2030-12-31",{"name":506,"class":507},"Vastra Gotaland Region","OTHER_GOV",6,{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":21,"phases":518,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":526,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100508708","phase-1-locoregional-administration-of-til-and-lymphodepletion-in-patients-with-melanoma-and-liver-metastases-100508708","NCT05903937","Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases","Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes Preconditioned With Percutaneous Hepatic Perfusion With Melphalan in Patients With Melanoma and Liver Metastases","HAITILS-PHP","Inclusion Criteria:\n\n* Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.\n* Patient must have a histologically\u002Fcytologically confirmed diagnosis of:\n* stage IV uveal melanoma with or without any previous systemic therapy OR\n* stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor.\n* Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.\n* At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.\n* ECOG performance status of 0 - 1.\n\nExclusion Criteria:\n\n* Life expectancy of less than 3 months.\n* Reduced renal function defined as S-Creatinine \\>=1.5xULN or Creatinine Clearance \\\u003C 40 mL\u002Fmin, calculated using the Cockroft and Gault formula.\n* Reduced hepatic function (defined as ASAT, ALAT, bilirubin \\> 3\\*ULN and PK- INR \\> 1.5) or medical history of liver cirrhosis or portal hypertension.\n* Hemoglobin \\\u003C90 g\u002FL or platelets \\\u003C100x109\u002FL or neutrophils \\\u003C1.5x109\u002FL\n* Use of live vaccines four weeks before or after the start of study.\n* Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.\n* Active autoimmune disease.\n* A condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.\n* Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.\n* 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",{"count":508,"type":20},[23],"Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma",[26,521],"Metastatic Cutaneous Melanoma",[523,524,525],"TIL","ACT","PHP","NOT_YET_RECRUITING","2023-06-05",{"date":529,"type":38},"2023-06-15",{"date":531,"type":20},"2023-12-31",{"date":533,"type":20},"2029-12-31",{"name":506,"class":507},{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":541,"enrollmentInfo":542,"targetDuration":544,"studyType":273,"phases":4,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":73},"100495632","retrospective-register-for-uveal-melanoma-100495632","NCT05733728","Retrospective Register for Uveal Melanoma","Inclusion Criteria\n\n* Patients 18 - 99 years\n* Diagnosis of uveal melanoma Exclusion Criteria\n* Patients younger than 18 years of age\n* Inadequate or missing information on the clinical course in patient charts","99 Years",{"count":543,"type":20},1400,"10 Years","Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs.\n\nAim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021.\n\nPatients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.",[26],"2023-05-02",{"date":549,"type":38},"2023-05-06",{"date":551,"type":38},"2023-01-23",{"date":504,"type":20},{"name":554,"class":44},"Medical University of Vienna",{"id":556,"slug":557,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":563,"phases":4,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":575,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":579,"locationsCount":4},"100436258","a-cohort-ind-expanded-access-program-for-supporting-patient-access-to-tebentafusp-100436258","NCT04960891","A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp","A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma","Non Applicable","Inclusion Criteria:\n\nAge\n\n1. Male or female patients age ≥ 18 years of age at the time of first dose\n\n   Type of Participant and Disease Characteristics\n2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n3. HLA-A\\*02:01 positive\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\n   Informed Consent\n5. Ability to provide and understand informed consent prior to procedures \\[if required\\]\n\n   Contraception\n6. Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 1 week after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n\n   1. Pregnant or lactating women are prohibited from enrolling on this program.\n   2. Male participants are not allowed to donate sperm from the time of enrolment until 3 months post- administration of program interventions.\n\nExclusion Criteria:\n\nDisease Under Study and Prior Anticancer Therapy\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:\n\n   1. Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and\u002For radiation).\n   2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to first planned administration of tebentafusp.\n2. Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of program intervention:\n\n   1. Cellular therapies (e.g., T-cell therapies): 90 days.\n   2. Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies (e.g., ipilimumab): 28 days\n   3. All other immunotherapies, including PD-(L)1-targeted immunotherapies (e.g., atezolizumab, pembrolizumab): 21 days\n   4. All other systemic therapies: 14 days\n   5. Radiotherapy: 14 days (excepting palliative radiotherapy to a limited field \\[e.g., for a focally painful tumor mass\\], which may be administered within 14 days provided there are no ongoing related Grade 2 or higher toxicities)\n\n   Medical Conditions and Concomitant Medications\n3. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:\n\n   1. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.\n   2. Local steroid therapies (e.g., optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n   3. Premedication for allergy to contrast reagent.\n   4. Steroids for management of CNS metastases \\> 2 weeks prior to the planned first dose of program intervention.\n4. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n5. Chronic viral infections as indicated below. NOTE: Testing for hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.\n\n   1. Known history of human immunodeficiency virus (HIV) infection.\n   2. Known HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening.\n   3. Known HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable during Screening.\n\n   Diagnostic Assessments\n6. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor.\n\n   1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 30 mL\u002Fminute\n   2. Total bilirubin \\> 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 × ULN or direct bilirubin \\> 1.5 × ULN\n   3. Alanine aminotransferase \\> 5 × ULN\n   4. Aspartate aminotransferase \\> 5 × ULN\n   5. Platelet count \\\u003C 50 × 109\u002FL\n   6. Hemoglobin \\\u003C 8 g\u002FdL\n7. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n   1. Congestive heart failure (New York Heart Association Class ≥ 3)\n   2. Uncontrolled hypertension defined as systolic blood pressure \\[BP\\] \\> 160 mmHg or diastolic BP \\> 110 mmHg with the following requirements:\n\n   \u003C!-- -->\n\n   1. If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart.\n   2. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart.\n   3. Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to the planned first dose of program intervention","EXPANDED_ACCESS","This Expanded Access Program aims to:\n\n1. Provide access to tebentafusp for mUM patients.\n2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window.\n3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.",[26],[27,567,568,60,89,159,569,26,570,571,572,573,574],"Uveal Cancer","IMCgp100","Eye Melanoma","Gp100","TCR","Bispecific T cell receptor fusion protein","ImmTAC","Immune mobilizing monoclonal T cell receptor against cancer","AVAILABLE","2022-01-05",{"date":578,"type":38},"2022-01-21",{"name":580,"class":175},"Immunocore Ltd",{"id":582,"slug":583,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":73},"100166350","assessing-the-clinical-effectiveness-of-serum-biomarkers-in-the-diagnosis-of-metastatic-uveal-melanoma-100166350","NCT01438658","Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma","UM","Inclusion Criteria:\n\n* diagnosis of uveal melanoma\n\nExclusion Criteria:\n\n* refusal to participate in the study",{"count":589,"type":20},250,"Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients.\n\nMany serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma.\n\nThe investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.",[26],[191,439],"2011-09-27",{"date":595,"type":20},"2011-09-28",{"date":597,"type":4},"2011-09",{"date":599,"type":20},"2040-12",{"name":601,"class":44},"Hadassah Medical Organization"]