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

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/

Conditions

• Melanoma, Cutaneous Malignant

Interventions

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)

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)

Sponsors & Collaborators

• Immatics US, Inc.

  lead INDUSTRY

Principal Investigators

• Cedrik Britten, M.D. · Immatics US, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-14

Primary Completion

2028-01-31

Completion

2031-10-31

FDA Drug

Yes

Countries

• United States
• Canada
• Germany
• United Kingdom

Study Locations