SUPRAME-IMA203 vs. investigator’s choice of treatment in unresectable/metastatic cutaneous melanoma
Research type
Research Study
Full title
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)
IRAS ID
1012574
Contact name
Immatics Medical Affairs
Contact email
Sponsor organisation
Immatics US, Inc.
Eudract number
2024-517062-42
Clinicaltrials.gov Identifier
Research summary
Immatics is developing a new cancer treatment called IMA203 (anzutresgene autoleucel or anzu-cel). This treatment
uses the body's own immune cells, known as T cells, that have been genetically modified to help fight cancer. For
IMA203 to work best, a specific type of HLA molecule (biomarker) is needed. A specific biomarker in tumour tissue,
known as PRAME, is also required for IMA203 to work, which is very common in skin (cutaneous) melanoma.
The purpose of this study is to confirm whether IMA203 is safe and works well in patients with pre-treated, advanced,
or metastatic skin (cutaneous) melanoma. In this study, IMA203 is compared against the investigator’s choice of
standard of care therapy for treatment of skin melanoma as outlined in the Clinical Trial Protocol which includes a
predefined list of approved and available treatments. The study is "open label" and participants will know which
treatment they receive. Participants will be randomly assigned with 50% chance to the treatment: either IMA203 or
investigator's choice (known as randomization, like the flip of a coin). This study will consist of the following:
- Screening period and eligibility assessments
- Treatment phase
- Follow-up period
The study will end 5 years after the last patient has started treatment. The length of the study for each patient will vary.
Patients treated with IMA203 will further be monitored for long-term safety (up to 15 years).
The clinical trial is funded by Immatics US Inc., and will enroll 360 patients in the US, Canada and in Europe.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0390
Date of REC Opinion
12 Feb 2026
REC opinion
Further Information Favourable Opinion