A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase III clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator's choice in patients with previously treated, unresectable or metastatic cutaneous melanoma
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Melanoma (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Sharma, Bhavina
Contact Information:
Michaela Savine
misavine@unmc.edu
Summary
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of IMA203 compared with control (investigator's choice) in terms of Progression-free survival (PFS), centrally assessed (by a BICR) using RECIST v1.1.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of IMA203 compared with control (investigator's choice) in terms of overall survival (OS).
II. To evaluate the efficacy of IMA203 compared with control (investigator's choice) in terms of PFS locally assessed using RECIST v1.1 and ORR consisting of CR and PR based on BOR, locally and centrally assessed using RECIST v1.1.
III. To evaluate safety and tolerability of treatment with ACTengine IMA203 product compared with control (investigator's choice).
IV. To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice).