SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Conditions

• Melanoma, Cutaneous Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IMA203 — BIOLOGICAL
  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 — BIOLOGICAL
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• lifileucel — BIOLOGICAL
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• nivolumab — BIOLOGICAL
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• pembrolizumab — BIOLOGICAL
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• ipilimumab — BIOLOGICAL
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• Dacarbazine — DRUG
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• temozolomide — DRUG
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• paclitaxel — DRUG
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• paclitaxel plus carboplatin — DRUG
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
• Albumin-Bound Paclitaxel — DRUG
  in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Study Details

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/

Key Dates

First listed

Dec 19, 2024

Start date

Jan 14, 2025

Status verified

Jun 2026

Primary completion

Jan 31, 2028

Completion

Oct 31, 2031

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental arm
  Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), 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
• Active Comparator: Control arm- investigator's choice
  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), optional bridging therapy.

Primary Outcome Measure

Progression-free survival assessed by BICR [ Time Frame: up to 5 years post first treatment of last patient ]

Central Contacts

• Immatics US, Inc.
  +1 346 204-5400
  [email protected]

Locations (40)

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