[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-or-metastatic-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-or-metastatic-melanoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053620","early-phase-1-picstat-pilot-study-for-cd8-petct-guided-lifileucel-treatment-in-advanced-melanoma-100053620",false,"NCT07700121","PICSTAT Pilot Study for CD8 PET\u002FCT-Guided Lifileucel Treatment in Advanced Melanoma","PICSTAT (PET Imaging of CD8 for Selection of Tumors for Autologous TIL): A Pilot Study Assessing the Use of CD8 PET\u002FCT (Zr-89 Crefmirlimab Berdoxam) to Enhance Lifileucel (AMTAGVI) Efficacy in Patients With Treatment Refractory Stage IV Melanoma","PICSTAT","Inclusion Criteria:\n\n* Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV)\n* Participants must have progressed following ≥ 1 prior systemic therapy for Stage IV or unresectable Stage III disease including a PD- 1 blocking antibody; and if BRAF V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor.\n* At least two resectable previously non-irradiated lesions (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post- resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)\n* Lesions in the spleen should not be selected as resectable lesions, because they are not well evaluated by CD8 PET\u002FCT imaging due to high background signal in that organ\n* In addition to the two resectable lesions, at least one measurable target lesion, as defined by RECIST v1.1\n\n  1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion\n  2. If a lesion is partially resected to generate TIL, and remains visible on the Baseline scan after surgery, then the partially resected lesion can be used for RECIST v1.1 response assessment, but only as a non- target lesion\n* Participants must be ≥ 18 years of age at the time of consent.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .\n* Participants must have signed informed consent for the PICSTAT companion CD8 PET imaging protocol.\n* Participants are eligible for treatment with AMTAGVI per the recommendation of the treating oncologist.\n* Participant (or legally authorized representative) is capable of giving signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Participants of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the protocol and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy\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 6.0.\n\nExclusion Criteria:\n\n* Participants who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Participant has melanoma of uveal\u002Focular origin.\n* Participants who have a history of hypersensitivity to any component or excipient of lifileucel (AMTAGVI) or other study drugs: a. Hypersensitivity to PET tracer b. LD chemo regimen (cyclophosphamide, mesna, and fludarabine) c. Proleukin®, aldesleukin, IL-2 d. Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); (These participants may be eligible if current hypersensitivity has been excluded.) e. Any component of the lifileucel infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Participant has symptomatic untreated brain metastases. Participants with brain metastases may be considered for study participation with the following considerations and only after discussion with the Investigator:\n\n  1. Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.\n  2. A participant with historically treated brain metastases (i.e., treatment was completed \\>28 days prior to consenting for study participation) may be considered for study participation if the participant is clinically stable for ≥ 2 weeks, there are no new or worsening brain lesions via screening CT or MRI, and the participant does not require ongoing corticosteroid treatment (\\>10 mg\u002Fday prednisone or equivalent).\n  3. If there are progressive or new brain metastases on the screening CT or MRI, the participant should first receive treatment for them prior to restarting or continuing screening. A participant with recently treated brain metastases (i.e., treatment of brain metastases was completed ≤ 28 days prior to consenting for study participation) may be considered for study participation if the participant is asymptomatic, clinically stable for ≥ 2 weeks, and does not require corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) by the end of the screening period. Repeat brain imaging is not required after treatment.\n* Participant requires systemic steroid therapy \\> 10 mg\u002Fday of prednisone or another steroid equivalent dose.\n\nParticipants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg\u002Fday of prednisone or another steroid equivalent dose may be eligible\n\n* Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening\n* Participants who are pregnant or breastfeeding.\n* Participants who have active medical illness(es) that would pose increased risk for study participation, including: active uncontrolled infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of LD chemo regimen.","ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This prospective, single-center pilot study is being performed to find out whether Zr-89 crefmirlimab berdoxam \"CD8 PET\u002FCT\" scans can improve the effectiveness of the tumor-infiltrating lymphocyte (TIL) therapy called lifileucel (\"Study Treatment\") in treating metastatic melanoma.\n\nParticipants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.",[27],"Unresectable or Metastatic Melanoma","NOT_YET_RECRUITING","2026-07-07",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-10-01",{"date":36,"type":21},"2029-10-01",{"name":38,"class":39},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100543745","phase-1-a-study-of-st-1898-for-unresectable-or-metastatic-melanoma-100543745","NCT06359860","A Study of ST-1898 for Unresectable or Metastatic Melanoma","A Phase Ib\u002FII Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Life expectancy of three months or more\n3. Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy\n4. Recommendation of subject offering archived tissue sample or previous biomarker test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core needle biopsy (fine needle biopsy not allowed)\n5. Eastern Cooperative Oncology Group performance status (PS) ≤ 1\n6. At least one measurable lesion per RECIST 1.1\n7. Has adequate organ function defined as follows:\n\n   * Absolute neutrophil count ≥ 1.5 ×10\\^9\u002FL, Platelets ≥ 75× 10\\^9\u002FL and Hemoglobin ≥ 90 g\u002FL (no blood transfusions, no platelet transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood test) at screening;\n   * Serum creatinine ≤1.5 × upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 2.5 ULN, AST\u002FALT ≤ 5 ULN for liver metastasis;\n   * Total bilirubin ≤ 1.5 ULN\n   * International normalized ratio (INR) ≤ 1.5 ULN, or prothrombin time (PT) ≤1.5 ULN\n   * Activated partial thromboplastin time (APTT) ≤1.5 ULN\n   * Serum albumin ≥30 g\u002FL\n8. Willing and able to provide written Informed consent.\n9. Eligible male and female subjects with fertility activity or their sexual partners must use effective contraception during study period and though 90 days after last study treatment. Women of child-bearing age must have a negative serum pregnancy test within 7 days before first study treatment\n\nExclusion Criteria\n\n1. Subjects with one of the following conditions prior to first dose, including, but not limiting to：\n\n   * A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.;\n   * A history of oral fluoropyrimidines and small molecular targeted-drug therapy within 2 weeks or 5 half-life time （the longer time taken as final）;\n   * A history of traditional Chinese medicine with antitumor indication within 2 weeks;\n2. A history of being participant in clinical trial of other unapproved drugs within 4 weeks;\n3. A major operation or severe trauma within 4 weeks, （except tumor biopsy, puncture,）invasive dental procedures such as dental extraction, dental implants etc.\n4. Current or previous severe retinopathy who, in the judgment of the Investigator, are not suitable for enrollment\n5. A history of clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:\n\n   * Severe arrhythmia or heart conduction disturbance, such as second-degree or third-degree atrio-ventricular block or ventricular arrhythmia indicated with medical intervention\n   * QTc (by Fridericia): male \\>450 ms, female \\>470 ms\n   * Major cardiovascular events within 6 months prior to first dose, including acute coronary syndrome, stroke, deep vein thrombosis, pulmonary-thromboembolism and other ≥Grade 3 arterial-thrombosis events, or congestive heart failure, or aortic dissection etc.；\n   * New York Heart Association Class ≥ II；\n   * Left ventricular ejection fraction（LVEF）\\\u003C50%；\n   * Uncontrolled hypertension (blood pressure≥140\u002F90 mmHg even with antihypertensive therapy)\n6. Subjects with active leptomeningeal disease or brain metastases without being well controlled, except subjects with asymptomatic or treated brain metastases being stable imaging between 12 weeks before screening；\n7. Subjects with interstitial lung disease or radiation pneumonia in needs of corticosteroids therapy\n8. Subjects with clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 7 days prior to first dose;\n9. Subjects with malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and superficial bladder transient cell carcinoma that have been cured)\n10. A history of ≥ grade 3 bleeding episodes within 6 months prior to first dose; or currently ≥ grade 2 hemorrhage, with angioneoplasm\u002F vascular malformation, with high bleeding risks (such as active peptic ulcer or esophageal varices)\n11. Within 2 weeks prior to first dose of concomitant medication with strong inducers of CYP3A4, strong inhibitors of CYP3A4, or substrates with narrow therapeutic windows of CYP3A4;\n12. Subjects with ≥ Grade 2 (by CTCAE) toxicities caused by previous therapy (not including ≤Grade 2 peripheral neuropathy, alopecia, or other tolerated and no possible safety hazard events as determined by the investigator);\n13. Subjects with active hepatitis B, unless HBV-DNA titer in the normal range (for subjects with positive HBsAg but HBV-DNA titer eligible, prophylactic antiviral therapy except interferon is allowed); active hepatitis C (ANTI-HCV positive)；\n14. Subjects with positive HIV antibodies or Treponema pallidum antibodies;\n15. Subjects with acute bacterial, viral or fungal infections, and in needs of systemic antimicrobial therapy;\n16. Pregnant or lactating females;\n17. Subjects with significant neuropsychiatric disorders, leading to poor compliance;\n18. Subjects with underlying diseases (including abnormal laboratory investigations), alcohol, drug abuse, or drug dependence, all which affect the interpretation of toxicities or adverse event, or decrease;\n19. Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc.;\n20. Subjects with significant liver cirrhosis, hepatatrophy, portal hypertension, or more than moderate volume of ascites;\n21. A history of organ transplant;\n22. A history of other severe systemic disease, or not suitable as determined by the investigator due to any other reasons;\n23. A history of inoculation with live vaccine within 28 days prior to first dose. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is permitted. Inactivated COVID-19 vaccines are permitted. COVID-19 mRNA vaccines are not allowed. Intranasal influenza vaccines are live vaccines and are not allowed.",{"count":49,"type":21},64,[51,52],"PHASE1","PHASE2","ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.\n\nIn phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.\n\nIn phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets.",[27],[56,57],"ST-1898","Melanoma","RECRUITING","2025-08-22",{"date":61,"type":32},"2025-08-24",{"date":63,"type":32},"2023-11-07",{"date":65,"type":21},"2026-12",{"name":67,"class":68},"Beijing Scitech-Mq Pharmaceuticals Limited","INDUSTRY"]