[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-uveal-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-uveal-melanoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,77,108,140,172,188,220,240,261,282,315,343],{"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":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100641290","phase-1-a-phase-1-and-2-study-of-vmd-102-in-hepatocellular-carcinoma-and-other-solid-tumors-100641290","NCT07636785","A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","SPKTAHC","Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and\u002For metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g\u002FdL (SI Units: 90 g\u002FL) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000\u002Fmm3 (60 x109\u002FL) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (1.5x109\u002FL) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\\u003C30% of the TBIL)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and\u002For ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL\u002Fmin using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g\u002Fd\u002FL.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and\u002For tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs\u002Fsymptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU\u002FmL. Participants on active HBV therapy with viral loads \\\u003C100 IU\u002FmL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue\u002Forgan transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and\u002For substances abuse, Phosphatidylethanol (Peth) must be \\\u003C50 ng\u002FmL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","75 Years",{"count":56,"type":20},111,[23,58],"PHASE2","This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver\u002FHCC tumor models and preclinical toxicology and pharmacology studies support this study.",[61,28,62,63,64],"Hepatocellular Carcinoma (HCC)","Renal Cell Carcinoma (RCC)","Nonsmall Cell Lung Cancer","Colorectal Cancer (CRC)","NOT_YET_RECRUITING","2026-06-16",{"date":68,"type":38},"2026-06-18",{"date":70,"type":20},"2026-06",{"date":72,"type":20},"2031-12",{"name":74,"class":75},"VM Discovery, Inc.","INDUSTRY",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":76},"100564233","phase-1-tebentafusp-tebn-with-ldt-in-metastatic-um-100564233","NCT06626516","Tebentafusp-tebn With LDT in Metastatic UM","A Phase I\u002FII Study of Tebentafusp-tebn in Combination With Liver-Directed Therapies for the Treatment of Metastatic Uveal Melanoma","Inclusion Criteria\n\n1\\. Age ≥18 years of age 2. Histologically or cytologically confirmed metastatic uveal melanoma in the liver. Patients must have at least one measurable liver metastasis that is ≥ 10 mm in longest diameter by CT scan or MRI. Extra-hepatic disease is allowed. 3. Tumor Size Criteria: i. Part 1: Total volume of tumor must be \\\u003C 50% of the liver involvement by CT or MRI; M1a or M1b disease with largest tumor ≤ 5 cm ii. Part 2: M1b disease with largest tumor \\> 5 cm, M1c disease, or ≥ 50% liver involvement by CT or MRI 4. No prior systemic treatment with tebentafusp-tebn 5. Prior therapy: i. Part 1: Patients must be treatment naïve in the metastatic setting.\n\n1. Prior surgery or ablation for oligometastatic disease is allowable.\n2. Palliative radiation of non-target lesions also allowable. ii. Part 2: Patients may have had prior systemic therapy with chemotherapy, immunotherapy, or targeted therapy. They can also have had prior liver directed therapy including surgery, ablation, immunoembolization, or radioembolization. However cannot have had more than two prior lines of treatment total.\n\n6\\. HLA-A\\*0201 positive 7. ECOG performance status or 0 or 1 at the time of screening 8. Life expectancy of greater than 3 months as assessed by the investigator 9. Patients must have normal organ and bone marrow function as defined below:\n\n1. Platelet count ≥ 100,000\u002Fmm³\n2. Hemoglobin \\> 8.0g\u002FdL\n3. ANC ≥ 1500\n4. AST and\u002For ALT \\\u003C 3x upper limited of normal (ULN)\n5. Total bilirubin ≤ 2.0 mg\u002Fml\n6. Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and\u002For the principal investigator.\n7. PT\u002FPTT \\\u003C 1.5x ULN\n8. Creatinine clearance \\> 60mL\u002Fmin\n9. Potassium, magnesium, corrected calcium, and phosphate within normal laboratory parameters 10. Women must not be pregnant or breast-feeding. 11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for the 6 months after the final dose of the study drug. Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n   12\\. Male patients treated or enrolled on this protocol must be surgically sterile or use double barrier contraception methods from enrollment through treatment, and for 6 months after completion of study therapy.\n\n   13\\. Ability to understand and the willingness to sign a written informed consent document.\n\n4.1.2 Exclusion Criteria\n\n1. Parts 1 and 2:\n\n   1. Failure to meet any of the criteria set forth in the Inclusion criteria section\n   2. History of prior tebentafusp-tebn use\n   3. Prior chemoembolization in Part 2 is not permitted\n   4. History of severe immediate or delayed hypersensitivity reaction to biologic drugs, monoclonal antibodies, iodinated contrast agent\n   5. Presence of symptomatic liver failure including ascites and hepatic encephalopathy\n   6. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids within 21 days prior to initiation of study therapy. Patients with brain metastases may be eligible if lesions have been treated with local therapy and there is no evidence of CNS disease progression for at least 4 weeks as measured by MRI prior to first dose of study drug\n   7. History of another malignancy except for: 1) those who have been disease-free for 3 years prior to study treatment; 2) patients with a history of completely resected non-melanoma skin cancer; 3) patients with indolent secondary malignancies not requiring active therapy; 4) patients with completely resected carcinoma in situ. Consult the study Principal Investigator if unsure whether second malignancies meet the requirements specified above.\n   8. 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   9. 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   10. No outstanding toxicities from prior therapies greater than Grade 1. Except for prior immune related side effects such as endocrinopathy that are managed with a stable dose of thyroid or steroid supplement.\n   11. Use of any 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 therapy and during the study.\n   12. Use of hematopoietic colony-stimulating growth factors (eg. G-CSF, GMCSF, M-CSF) within 14 days prior to study treatment initiation. 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   13. Known history of human immunodeficiency virus infection (HIV). Testing for HIV is not necessary unless clinically indicated\n   14. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing for HBV or HCV status is not necessary unless clinically indicated or if the patient has a history of HBV or HCV infection.\n   15. Patients receiving systemic steroid therapy or any immunosuppressive medication. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable.\n   16. History of bleeding diathesis\n   17. Pregnant, likely to become pregnant, or breastfeeding women\n   18. Uncontrolled concurrent illness, evaluated at investigator discretion\n   19. Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy, or any anatomic abnormalities that would interfere with immunoembolization or chemoembolization:\n   20. Patients with occlusion of the main portal vein\n   21. Inadequate collateral flow around an occluded portal vein as determined by angiography\n   22. Arteriovenous shunt identified on arteriography of the hepatic artery\n   23. Any medical condition that, in the Investigator's judgement, would prevent patient participation in the clinical study due to safety concerns, compliance with study procedures or interpretation of study results\n2. Part 1 Only:\n\n   1. History of severe immediate or delayed hypersensitivity reaction to GM-CSF",{"count":85,"type":20},109,[23,58],"This study is a multicenter, open label phase I\u002F II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.",[28],[90,91,92,93,94,95,96,97,98,99],"Uveal","uveal melanoma","metastatic uveal melanoma","melanoma","Liver-directed therapy","Liver-directed","Liver","liver-directed therapies","MUM","LDT","2026-06-12",{"date":66,"type":38},{"date":103,"type":38},"2025-10-15",{"date":105,"type":20},"2032-08",{"name":107,"class":44},"Thomas Jefferson University",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100358462","phase-1-study-of-ide196-in-patients-with-solid-tumors-harboring-gnaq11-mutations-or-prkc-fusions-100358462","NCT03947385","Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","A Phase 1\u002F2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","Inclusion Criteria:\n\n* Patient must be ≥18 years of age and able to provide written informed consent\n* Diagnosis of the following:\n\n  o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed.\n\n  \\- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\\*02:01 positive\\*\\*\\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp.\n\n  \\*\\*\\*To be enrolled in the HLA-A\\*02:01 positive cohort, HLA status must be documented by test results from a CAP\u002FCLIA-certified laboratory.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \\> 3 months\n* Adequate organ function at screening\n* Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential\n\nCrizotinib Combination Additional Inclusion Criteria:\n\n* Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib\n* Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients\n* Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.\n\nExclusion Criteria:\n\n* Previous treatment with a PKC inhibitor\n* Known MSI-H\u002FdMMR tumors who have not previously received immune checkpoint inhibitors\n* Known symptomatic brain metastases\n* Adverse events from prior anti-cancer therapy that have not resolved\n* Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus\n* Active infection requiring ongoing therapy\n* Recent surgery or radiotherapy\n* Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect\n* Females who are pregnant or breastfeeding\n* Impaired cardiac function\n* Treatment with prohibited medications that cannot be discontinued prior to study entry\n* For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin\n\nCrizotinib Combination Additional Exclusion Criteria:\n\n* Prior therapy directly targeting ALK, MET, or ROS1\n* Spinal cord compression\n* History of pneumonitis or interstitial lung disease\n* History of syncope\n* History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment\n\nPK Substudy (optional) with Pravastatin Additional Exclusion Criteria:\n\n* Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1\n* Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin\n* Any contraindication associated to the use of statins or hypersensitivity component of pravastatin\n* Active liver disease\n\nDDI Cocktail Substudy Additional Exclusion Criteria:\n\n* Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.\n* Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit\u002Fgrapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.\n* Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Moderate and strong inhibitors of CYP2A4\u002F5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Intake of strong or moderate inducers of CYP3A4\u002F5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.",{"count":116,"type":20},336,[23,58],"This is a Phase 1\u002F2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ\u002F11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.\n\nPhase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study.\n\nCrizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.\n\nAs of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.",[28,120,121,122],"Cutaneous Melanoma","Colorectal Cancer","Other Solid Tumors",[28,26,124,125,126,127,128,129],"Protein Kinase C","Ophthalmology","Ocular Oncology","Darovasertib","IDE196","Ocular Melanoma","2026-06-04",{"date":132,"type":38},"2026-06-08",{"date":134,"type":38},"2019-06-28",{"date":136,"type":20},"2027-06-15",{"name":138,"class":75},"IDEAYA Biosciences",15,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":76},"100641091","phase-1-dual-target-cspg4gd2-car-nk-cells-for-advanced-melanoma-100641091","NCT07627698","Dual-Target CSPG4\u002FGD2 CAR-NK Cells for Advanced Melanoma","An Open-Label, Multicenter Phase 1\u002F2 Study of Allogeneic Dual-Target CSPG4\u002FGD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma","DUET-MEL","Inclusion Criteria:\n\n* Age 18-75 years at consent.\n* Histologically confirmed unresectable\u002Fmetastatic cutaneous melanoma or metastatic uveal melanoma.\n* Disease progression after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit. For cutaneous melanoma: prior anti-PD-1\u002FL1 (with or without antiCTLA-4) unless contraindicated; if BRAF V600-mutant, prior BRAF\u002FMEK inhibitor therapy or documented unsuitability. For uveal melanoma: prior tebentafusp if HLA-A\\*02:01-positive and eligible, or documented unsuitability\u002Funavailability plus at least one prior systemic therapy.\n* Tumor demonstrates CSPG4 and\u002For GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable tumor cells by IHC or equivalent validated assay).\n* At least 1 measurable lesion by RECIST v1.1.\n* ECOG performance status 0-1.\n* Adequate bone marrow, renal, hepatic, cardiac, and pulmonary function per protocol.\n* Life expectancy of at least 12 weeks.\n* Treated, stable brain metastases are allowed if neurologically stable for at least 4 weeks and not requiring escalating corticosteroids.\n* Willingness to use effective contraception and comply with protocol-required visits, blood sampling, and requested biopsies.\n\nExclusion Criteria:\n\n* Active symptomatic CNS metastases, leptomeningeal disease, or uncontrolled seizure disorder.\n* Prior allogeneic stem cell transplant or solid organ transplant; prior gene-modified cellular therapy within 12 weeks; or anti-cancer therapy too close to lymphodepletion per protocol washout rules.\n* Requirement for systemic immunosuppression greater than 10 mg prednisone equivalent\u002Fday or uncontrolled autoimmune\u002Finflammatory disease requiring systemic treatment.\n* Active uncontrolled infection, including uncontrolled HIV, HBV, or HCV, or fever\u002Fsepsis at the time lymphodepletion would begin.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, recent myocardial infarction, or uncontrolled thromboembolic disease.\n* Grade 2 or higher unresolved toxicities from prior therapy, except stable endocrinopathy, alopecia, or vitiligo.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or CAR-NK infusion unsafe.",{"count":149,"type":20},36,[23,58],"This is a first-in-human, open-label, multicenter phase 1\u002F2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4\u002FGD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy",[153,154,28],"Unresectable Melanoma","Metastatic Cutaneous Melanoma",[156,157,158,159,160,91,161,162,163],"CAR-NK","allogeneic NK cells","CSPG4","GD2","advanced melanoma","cell therapy","biomarker-guided","solid tumor","2026-05-31",{"date":130,"type":38},{"date":167,"type":38},"2026-03-02",{"date":169,"type":20},"2028-06-17",{"name":171,"class":75},"Beijing Biotech",{"id":173,"slug":4,"hasResults":11,"nctId":12,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":24,"conditions":180,"keywords":181,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":187,"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":178,"type":20},30,[23],[26,27,28,29],[26,27,28,29,31,32,33],"2026-05-26",{"date":184,"type":38},"2026-05-28",{"date":40,"type":38},{"date":42,"type":20},{"name":33,"class":44},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100560765","phase-2-a-randomized-phase-23-study-to-investigate-the-efficacy-and-safety-of-rp2-in-combination-with-nivolumab-in-immune-checkpoint-inhibitor-nave-adult-patients-with-metastatic-uveal-melanoma-100560765","NCT06581406","A Randomized, Phase 2\u002F3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma","A Randomized, Phase 2\u002F3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma","Key Inclusion Criteria:\n\n* Patients who are 18 years of age or older at the time of signed informed consent.\n* Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.\n* Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \\[LN\\]) that is amenable to serial RP2 injections.\n* Must be willing to provide tumor biopsy samples.\n* LDH ≤ 2 × upper limit of normal (ULN).\n* Has adequate hematologic, hepatic and renal function\n* Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \\[INR\\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n* Life expectancy of \\> 6 months as estimated by the Investigator.\n\nKey Exclusion Criteria:\n\n* Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.\n* Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n* Current active significant herpetic infections or prior complications of HSV-1 infection.\n* Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.\n* Major surgery ≤ 2 weeks prior to the first dose of study intervention.\n* Any bleeding, thrombotic and\u002For other event that places the patient at an unacceptable risk of complications of intratumoral therapy.\n* Active, known, or suspected autoimmune disease requiring systemic treatment.\n* Prior treatment with an oncolytic virus.\n* Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n* Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.\n* Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.\n* Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.\n\nAdditional inclusion\u002F exclusion criteria are outlined in the study protocol",{"count":196,"type":20},280,[58,198],"PHASE3","The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.",[28],[202,90,27,203,204,205,206,207,208,209],"Metastatic","Nivolumab","Ipilimumab","Randomized","Immune checkpoint inhibitor-naïve","RP2","Oncolytic viruses","HSV-1","2026-03-31",{"date":212,"type":38},"2026-04-02",{"date":214,"type":38},"2024-12-17",{"date":216,"type":20},"2031-10",{"name":218,"class":75},"Replimune, Inc.",33,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":76},"100614191","phase-2-phase-2-combination-of-melphalanhds-via-php--tebentafusp-in-treating-metastatic-uveal-melanoma-100614191","NCT07276386","Phase 2 Combination of Melphalan\u002FHDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma","Phase 2 Sequential Treatment With Melphalan\u002FHDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma","Inclusion Criteria:\n\n* Patient is ≥18 years of age on the day of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically or cytologically confirmed liver metastasis of uveal melanoma.\n* HLA-A\\*02:01 positive status.\n* Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver.\n* Patient deemed suitable for PHP and tebentafusp.\n* 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.\n* 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.\n* 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* Limited extrahepatic disease would be allowed initially, that can be treated with stereotactic body radiation therapy (SBRT) or surgical resection prior to the start of tebentafusp. This concept is similar to the FOCUS trial - definition of \"treatable\" limited disease at the discretion of the PI.\n* Ability to provide and understand written informed consent prior to any study procedures.\n\nExclusion Criteria:\n\n* Life expectancy of less than 6 months.\n* More than 50% of the liver volume replaced by tumor as measured by MRI.\n* Extrahepatic disease as measured by CT of thorax abdomen and pelvis. (See inclusion criteria #10 above for limited treatable extrahepatic disease.)\n* 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.\n* History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.\n* Patients who are unable to undergo general anesthesia for any reason.\n* Reduced renal function defined as Serum Creatinine \\>=1.5xULN or Creatinine Clearance \\\u003C 40 mL\u002Fmin, calculated using the Cockcroft and Gault formula.\n* Reduced hepatic function (defined as AST, ALT, bilirubin\\>2.5\\*ULN and PT-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.\n* Hemoglobin \\\u003C90 g\u002FL or platelets \\\u003C100x109\u002FL or neutrophils \\\u003C1.5x109\u002FL.\n* Use of live vaccines four weeks before the last study treatment.\n* History of severe reactions to melphalan, heparin or iodine contrast. Iodine contrast reaction history patients permitted if patient will be treated with pre-meds, or if still problematic, treating physician may switch to MRI TAP.\n* Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.\n* Active autoimmune disease or a documented history of autoimmune disease requiring active systemic immunosuppressive treatment. Type-1 diabetes, atopic dermatitis, and hypothyroidism are exceptions to this.\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 (other than physiologic (i.e., \\>10 mg) doses of steroids or as specified in exclusion #14) or use of other investigational drugs.\n* Has a known additional malignancy that is progressing or requires active treatment.\n* 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.\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.\n* Previous treatment with PHP or tebentafusp.",{"count":228,"type":20},18,[58],"This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan\u002FHDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\\*02:01-positive patients.",[28],"2026-03-26",{"date":210,"type":38},{"date":235,"type":38},"2025-12-31",{"date":237,"type":20},"2030-12",{"name":239,"class":44},"H. Lee Moffitt Cancer Center and Research Institute",{"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":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":76},"100564289","phase-2-study-of-tebentafusp-and-radioembolization-in-the-treatment-of-metastatic-uveal-melanoma-100564289","NCT06627244","Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma","Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma","Inclusion Criteria:\n\n1. Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review\n2. Serum bilirubin \\\u003C2 mg\u002Fdl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x upper limit of normal (ULN)\n3. Mapping angiogram procedure shows radioembolization is feasible and safe to perform\n4. Human leukocyte antigen-A\\*02:01(HLA A⁕ 02:01) positive\n5. Patient age ≥ 18 years old\n6. Ability to provide and understand written informed consent\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n8. Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).\n\nExclusion Criteria:\n\n1. Patient with any tumor size \\> 8 cm\n2. 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\n3. Clinical laboratory measurements that meet any of the following criteria:\n\n   * Alanine aminotransferase (ALT) \\> 3 × ULN\n   * Aspartate aminotransferase (AST) \\> 3 × ULN\n   * Absolute neutrophil count (ANC) \\\u003C 1.0 × 10\\^9 cells\u002FL\n   * Absolute lymphocyte count \\\u003C 0.5 × 10\\^9 cells\u002FL\n   * Platelet count \\\u003C 75 × 109 platelets\u002FL\n   * Hemoglobin \\\u003C 8 g\u002FdL\n4. Angiogram shows vascular shunting which prevents radioembolization\n5. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies\n6. Patients with clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n   * Congestive heart failure (New York Heart Association Class ≥ 3).\n   * Uncontrolled hypertension (consistent findings of systolic blood pressure \\[BP\\] \\> 160 mmHg or diastolic BP \\> 110 mmHg).\n   * History of ventricular arrhythmia currently requiring medical treatment.\n   * Uncontrolled atrial fibrillation.\n   * Electrocardiogram (ECG) QT interval corrected for heart rate by Fridericia's method (QTcF) \\> 470 msec during screening obtained on triplicate ECGs or known history of congenital prolonged QT syndrome.\n   * Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to screening.\n7. Presence of symptomatic or untreated central nervous system (CNS) metastases or CNS metastases that require doses of corticosteroids within 14 days prior to study treatment Day 1.\n8. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of Tebentafusp.\n9. Known history of human immunodeficiency virus (HIV) infection. Testing for HIV status is not necessary unless clinically indicated.\n10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection.\n11. Malignant disease other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.\n12. Any medical condition that would, in the Investigator's or Sponsor's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results\n13. Patients who received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of the planned first dose of study intervention. The following exceptions are permitted (Section 4.9.1):\n\n    * Treatment for well-controlled and asymptomatic adrenal insufficiency, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.\n    * Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications).\n    * Premedication for allergy to contrast reagent.\n    * Steroids for management of CNS metastases \\> 14 days prior to the planned first dose of study intervention.\n    * To treat asthma or chronic obstructive pulmonary disease exacerbations \\> 14 days prior to the planned first dose of study intervention (only short-term oral or IV use in doses \\> 12 mg\u002Fday prednisone equivalent).\n    * For inhalation in the management of asthma or chronic obstructive pulmonary disease.\n    * Any premedications required per protocol.\n14. Patient with morning cortisol \\\u003C lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses). For additional information regarding patients with adrenal insufficiency.\n15. History of interstitial lung disease\n16. History of pneumonitis that required corticosteroid treatment or current pneumonitis\n17. Patients 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\n    * Vitiligo\n    * Alopecia\n    * Managed hypothyroidism (on stable replacement doses)\n    * Asymptomatic adrenal insufficiency (on stable replacement doses) (For additional information regarding patients with adrenal insufficiency.\n    * Psoriasis\n    * Resolved childhood asthma\u002Fatopy\n    * Well-controlled asthma\n    * Type I diabetes mellitus\n18. 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)\n19. 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\n20. Use of hematopoietic colony-stimulating growth factors (eg, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), macrophage colony-stimulating factor (M-CSF)) ≤ 3 weeks prior to start of Tebentafusp. An erythroid-stimulating agent is allowed as long as it was initiated at least 3 weeks prior to the first dose of study treatment and the patient is not red blood cell (RBC) transfusion dependent. For more information on the timing and use of hematopoietic colony-stimulating growth factors during study.\n21. Patient receiving a live or attenuated vaccine(s) ≤ 28 days prior to the first dose of study intervention. Note: Non-live vaccines (including adenoviral and messenger ribonucleic acid (mRNA)-based coronavirus disease-2019 (COVID-19) vaccines) are allowed but are not to be administered for at least 2 weeks before and 3 weeks after start of study treatment and within 24 hours before or after study treatment administration following the first 3 weeks of study treatment.\n22. 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)\n23. Women of childbearing potential (WoCBP) 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 (defined in Section 4.12), and must agree to continue using such precautions for 6 months after the final dose of Tebentafusp; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 4.12.\n24. Male patients must be surgically sterile or use double barrier contraception methods as described in Section 4.12 from enrollment through treatment and for 6 months following administration of the last dose of Tebentafusp.\n25. Prior radioembolization or other regional, liver-directed therapy, including chemotherapy or embolization to same site in the liver\n26. Patients with impaired decision-making capacity.",{"count":178,"type":20},[58],"The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.",[28,251],"Metastatic Uveal Melanoma in the Liver","2026-02-20",{"date":254,"type":38},"2026-02-23",{"date":256,"type":38},"2025-02-14",{"date":258,"type":20},"2031-02-17",{"name":260,"class":44},"University of Miami",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100525395","phase-2-study-of-cemiplimab-plus-ziv-aflibercept-for-subjects-with-metastatic-uveal-melanoma-100525395","NCT06121180","Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma","A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Male or female, aged \\>\u002F= 18 years old.\n* Life expectancy of greater than 3 months in the opinion of the investigator.\n* Must be willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines.\n* Patients must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed.\n* Patients with histologically or cytologically confirmed metastatic melanoma or cutaneous, mucosal or unknown primary origin are also eligible. This includes AJCC stage IV or advanced\u002Finoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally\u002Fregionally advanced\u002Finoperable disease or distant metastases. These patients must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) as monotherapy or in combination and later experienced disease progression. Patients with BRAF V600 mutant melanoma must have previously received BRAF targeted therapy for metastatic melanoma and later experienced disease progression. Patients who refuse or decline to receive BRAF targeted therapy or prefer to delay or were intolerant of BRAF targeted therapy are eligible\n* Patients must have ECOG performance status of 0-1.\n* Patients must have measurable disease, according to RECIST version 1.1.\n* Patients must have normal organ and marrow function as defined in protocol.\n* Urine protein should be screened by urinalysis for Urine Protein Creatinine Ratio (UPCR). For UPCR \\> 1, a 24-hour urine protein should be obtained, and the level should be \\\u003C500 mg.\n* An echocardiogram should be performed at baseline in all patients. Ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist.\n* Patients on full-dose anticoagulants (e.g., warfarin) with PT INR \\>1.5 are eligible provided that both of the following criteria are met:\n\n  1. The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin.\n  2. The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).\n* A patient may be treatment naïve. However, prior systemic treatments for metastatic uveal melanoma are allowed. There is no limit on the number of prior regimens for metastatic uveal melanoma. However, no prior therapy with bevacizumab, aflibercept or cemiplimab.\n* Patients must be free of active brain metastasis by contrast-enhanced CT\u002FMRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study.\n* For Women of childbearing potential: use of highly effective contraception for at least 2 or more menstrual cycles prior to screening and agreement to use such a method during study participation and for at least 180 days after the end of study drugs administration.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner For at least 1 month prior to screening and agreement to use such a method during study participation and for at least 180 days after the end of study drugs administration.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Treatment with another investigational drug or other systemic intervention for uveal melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 4 weeks.\n\nPatients must have recovered from adverse events due to agents administered more than 4 weeks earlier.\n\n* Patients must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection.\n* Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids. A history of occasional (but not continuous) use of steroid inhalers is allowed.\n\nReplacement doses of steroids for patients with adrenal insufficiency are allowed. Patients who discontinue use of these classes of medication for at least 2 weeks prior to enrollment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study.\n\n* Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \\[e.g., Wegener's granulomatosis\\]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis); other central nervous system autoimmune disease (e.g., poliomyelitis, Multiple sclerosis).\n* Immunosuppressive corticosteroid doses (\\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab\u002Fplacebo. NOTE: Patients who require brief course of steroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded. People taking steroids for physiologic replacement (ie, adrenal insufficiency) are NOT excluded.\n* Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n* Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug related toxicity.\n* Encephalitis, meningitis, or uncontrolled seizures in the year prior to screening\u002Fenrollment.\n* History of immune related pneumonitis within the last 5 years.\n* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to the enrollment date.\n* Patients with a history of solid organ transplant (patients with prior corneal transplant(s) are not excluded).\n* Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible.\n* Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed).\n* Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of cemiplimab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.\n* Patients must not have an active infection requiring current treatment with parenteral antibiotics.\n* Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina.\n* Central nervous system: No history of cerebrovascular accident or transient ischemic attacks within the past 6 months.\n* Serious or non-healing wound, ulcer, or bone fracture.\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks of initiating study treatment.\n* Patients with the following invasive procedures:\n\n  * Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks of Day 1 of study therapy.\n  * Anticipation of need for major surgical procedures during the course of the study.\n  * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1 of study therapy. Central venous catheter placements are permitted to be completed 7 or more days prior to Day 1 of study therapy. However, peripherally inserted central catheter (PICC or PIC line) may be placed at any time prior to or during study therapy.\n* Patients with clinically significant cardiovascular or cerebrovascular disease:\n\n  * History of cerebrovascular accident or transient ischemic attack within past 6 months\n  * Uncontrolled hypertension, defined as blood pressure \\>150\u002F100 mm Hg or systolic BP \\>180 mm Hg if diastolic blood pressure \\\u003C90 mm Hg, on at least 2 repeated determinations on separate days within past 3 months.\n  * Myocardial infarction, coronary artery bypass grafting (CABG) or unstable angina within the past 6 Months.\n  * New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months.\n  * Clinically significant peripheral vascular disease within past 6 months.\n  * Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within past 6 months.\n* History of tumor-related or other serious hemorrhage, bleeding diathesis, or underlying coagulopathy.\n* PT INR \\>1.5 unless the patient is on full-dose warfarin.\n* Patients who have other current malignancies are not eligible. Patients with other malignancies are eligible if they have been continuously disease free for \\> 3 years prior to the time of enrollment. Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible. Patients with prior history of basal or squamous skin cancer are eligible. Patients who have had multiple primary melanomas are eligible.\n* Receipt of a live vaccine within 28 days of the enrollment date.\n* Women of childbearing potential or sexually active men, who are unwilling to practice highly effective contraception for at least 2 or more menstrual cycles (women) or 1 month (men) prior to screening, during the study, and for at least 180 days after the last dose of study drug(s).",{"count":269,"type":20},32,[58],"The goal of this clinical research study is to find out if Cemiplimab plus Ziv-Aflibercept is safe and effective in treating your condition of metastatic (spread to other parts of your body) uveal melanoma. This research study will test the study drugs to see if the combination of Cemiplimab plus Ziv-Aflibercept can make tumors shrink or stop growing.",[28],"2025-12-03",{"date":275,"type":38},"2025-12-04",{"date":277,"type":38},"2024-11-04",{"date":279,"type":20},"2030-10-31",{"name":239,"class":44},4,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100603412","phase-1-evaluation-of-the-safety-efficacy-and-pharmacokinetics-of-nbm-bmx-in-patients-with-metastatic-uveal-melanoma-100603412","NCT07136181","Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","A Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","NBM-BMX-UM","Inclusion Criteria:\n\n\\- Patients must meet the following criteria to be eligible for study entry:\n\n1. Signed, written IRB-approved informed consent.\n2. Men and women age ≥ 18 years\n3. ECOG Performance status ≤ 2\n4. Have measurable disease based on RECIST 1.1\n5. Histologic or cytologic confirmation of metastatic uveal melanoma\n6. Previous Therapy\n\n   * Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) has elapsed between any major surgery and date of registration, and that wound healing has occurred.\n   * Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.\n   * Other Systemic Therapy: There is no limit to the number of prior therapies received for metastatic uveal melanoma. Prior treatment with tebentafusp is required for HLA-A\\*02:01-positive patients unless unavailable or clinically inappropriate, as determined by the investigator. Prior HDAC inhibitor treatment is not permitted.\n\n   Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:\n\n   Longest of one of the following:\n   * Two weeks,\n   * 5 half-lives for investigational agents,\n\n     o For anti-cancer therapies with half-lives \\> 8 days, a washout period of at least 28 days will be acceptable,\n   * Standard cycle length of standard therapies.\n7. QTcF \\\u003C= 480 msec\n8. Adequate hematopoietic capacity, as defined by the following:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL and not transfusion dependent\n   * Platelets ≥ 100,000\u002Fmm3\n   * Absolute neutrophil count ≥ 1,500 cells\u002Fmm3\n9. Adequate hepatic function, as defined by the following:\n\n   * AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present\n   * Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease\n   * Albumin ≥ 3.0 g\u002FdL\n10. Adequate renal function, as defined by the following:\n\n    \\- Renal: calculated creatinine clearance \\>45 mL\u002Fmin for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula; Appendix F). For patients who are greater than 70 years old, investigator judgment may be used to assess the renal risk of study participation.\n11. Women\u002Fmen of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of NBM-BMX.\n12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nPatients who meet the following criteria will be excluded from study entry:\n\n1. Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 6 months after the last dose of NBM-BMX. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.\n2. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)\n3. History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.\n4. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.\n5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications.\n6. Difficulty with swallowing oral medications.\n7. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n8. A positive test for hepatitis B (HBsAg) and\u002For hepatitis C (anti-HCV antibody), unless the HBV DNA level and\u002For HCV RNA level is below the limit of detection.\n9. Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n10. Current use or anticipated need for P-gp or BCRP inhibitors during the study period.\n11. Use of proton pump inhibitors (PPIs), H2-receptor antagonists, or other systemic acid-reducing agents within 7 days prior to Cycle 1 Day 1 or planned use during the study treatment period, unless the patient can be switched to local antacids (e.g., calcium carbonate or aluminum hydroxide) taken at least 2 hours before or after NBM-BMX dosing.\n\nPatients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.",{"count":149,"type":20},[23,58],"This study is being done to find the best dose of an investigational drug called NBM-BMX for people with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body.\n\nThe study will help doctors learn about the side effects of NBM-BMX, how the drug is processed in the body, and whether it may slow down or shrink tumors.\n\nParticipants will take NBM-BMX as a capsule by mouth twice daily on an empty stomach with at least six ounces (180 mL) of water. No food or drink (other than water) should be consumed for at least two hours after each dose.\n\nParticipants will visit the clinic about once every week or two for exams and blood tests while taking NBM-BMX. After stopping treatment, a follow-up visit will occur about 30 days later.\n\nTreatment may continue as long as the cancer does not get worse and side effects remain manageable.",[28,294,295,296,297],"Uveal Melanoma, Metastatic","Uveal Melanoma, Recurrent","Eye Cancer, Intraocular Melanoma","Eye Cancer",[28,26,297,299,300,301,302,303,304],"Intraocular Melanoma","Choroidal Melanoma","NBM-BMX","Histone Deacetylase Inhibitor (HDAC inhibitor)","Phase 1b\u002F2 Study","Pharmacokinetics","2025-11-21",{"date":307,"type":38},"2025-11-28",{"date":309,"type":38},"2025-11-20",{"date":311,"type":20},"2029-08-30",{"name":313,"class":75},"Novelwise Pharmaceutical Corporation",3,{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":4},"100607076","phase-1-locoregional-or-systemic-administration-of-autologous-tumor-infiltrating-lymphocytes-in-patients-with-metastatic-melanoma-100607076","NCT07183852","Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma","GoTIL-01","Inclusion Criteria:\n\n1. Participants must be at least 18 years of age.\n2. Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.\n3. World Health Organization (WHO) Performance Status 0 or 1.\n4. Patient must have a histologically\u002Fcytologically confirmed diagnosis of:\n\n   * stage IV uveal melanoma with confirmed progression following prior systemic therapy with tebentafusp (if HLA A2:01 positive) OR\n   * stage IV cutaneous melanoma with confirmed progression following prior systemic therapy with a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor\n5. At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter to generate TILs.\n6. Measurable disease by computed tomography (CT) per RECIST 1.1 criteria after resection of lesion for TILs production\n7. No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.\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 a highly efficient method of contraception (Pearl index \\\u003C1), for the course of the study through 120 days after the last dose of study medication.\n10. Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results.\n2. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n3. Women who are pregnant or breastfeeding.\n4. Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.","90 Years",{"count":228,"type":20},[23],"The purpose of this study is to evaluate the feasibility, safety and tolerability of locoregional or systemic administration of autologous tumor infiltrating lymphocytes in patients with metastatic melanoma",[28,154],[328,329,330,331,332],"Adoptive Cell Therapy","Tumor Infiltrating Lymphocyte","Hepatic Arterial Infusion","Melphalan","Interleukin-2","2025-09-12",{"date":335,"type":38},"2025-09-19",{"date":337,"type":20},"2026-03",{"date":339,"type":20},"2033-03",{"name":341,"class":342},"Vastra Gotaland Region","OTHER_GOV",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"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":352,"type":20},8,[23,58],"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",[26,28,251],[92,357,358,359],"Immunotherapy","Treatment resistance","Combinational immunotherapy","2025-07-02",{"date":362,"type":38},"2025-07-14",{"date":364,"type":38},"2025-06-01",{"date":366,"type":20},"2027-09",{"name":368,"class":44},"St Vincent's Hospital, Sydney"]