SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)
About This Trial
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma. For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
IMA203
one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy
nivolumab plus relatlimab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
lifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
nivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
pembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
ipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Dacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
temozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Albumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)