Melanoma Clinical Trial
Safety and Efficacy of OBX-115 in Advanced/Metastatic Melanoma Resistant to Immune Checkpoint Inhibitors
This is a study to investigate the safety and efficacy of an investigational regimen, OBX-115, in adult participants with advanced/metastatic melanoma.
Primary Objective (Phase 1):
• Assess the safety and tolerability of OBX-115 regimen
Primary Objective (Phase 2):
• Evaluate preliminary efficacy of OBX-115 regimen in melanoma as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary (Phase 1):
• Assess preliminary efficacy of OBX-115 regimen by evaluating ORR
Secondary (Phase 2):
• Evaluate safety and tolerability of OBX 115 based on the collected AE data
Secondary (both Phase 1 and Phase 2):
Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to melanoma.
Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator.
Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause.
Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause
Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.
Participant must be 18 years of age or older at the time of signing the informed consent.
Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma.
Participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. If the tumor is BRAF V600 mutation-positive, the participant should also have received a BRAF inhibitor with or without a MEK inhibitor.
Participant is assessed as having at least one resectable lesion for OBX-115 generation.
After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of >6 months.
Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE]).
Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.
Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
Participant has adequate cardiac, liver and kidney organ function as specified in the protocol. Pulmonary function test may be required.
Participant has melanoma of uveal/ocular origin.
Participant has a history of brain metastases or leptomeningeal disease.
Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
Participant has any form of primary or acquired immunodeficiency.
Participant has a history of hypersensitivity to any component of the study intervention.
Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior non-engineered TIL therapy is allowed.
Participant requires systemic steroid therapy >10 mg/day of prednisone or equivalent.
Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
Participant has evidence of positive infectious disease screening infections requiring ongoing systemic treatment or identified during screening.
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