NCT06743126

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Immatics US, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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/

Detailed description

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening. Leukapheresis for potential manufacturing of the IMA203 cellular product may be performed, if patients are HLA-A\*02:01 positive and meet the eligibility criteria for leukapheresis. MANUFACTURING: IMA203 products will be made from the patients' white blood cells. TREATMENT- Experimental arm: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. TREATMENT- Control arm: Investigator's choice of treatment approved by the respective competent authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC).

Conditions

• Melanoma, Cutaneous Malignant

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	nivolumab plus relatlimab	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL	lifileucel	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL	nivolumab	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL	pembrolizumab	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
BIOLOGICAL	ipilimumab	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG	Dacarbazine	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG	temozolomide	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG	paclitaxel	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG	paclitaxel plus carboplatin	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
DRUG	Albumin-Bound Paclitaxel	in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Timeline

• Start date: 2025-01-14
• Primary completion: 2028-01-01
• Completion: 2031-10-01
• First posted: 2024-12-19
• Last updated: 2026-04-13

Locations

58 sites across 4 countries: United States, Canada, Germany, United Kingdom

Regulatory

• FDA-regulated drug study