Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing IMA203 for Melanoma, Cutaneous Malignant

This clinical trial is a prospective, multicenter, open-label, randomly assigned, actively controlled, parallel-group Phase 3 clinical trial to measure the how well it works, whether it is safe and how hard side effects are to live with 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 or mucosal melanoma (MM). For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/

Official registry: https://clinicaltrials.gov/study/NCT06743126 · Immatics US, Inc. · enrollment listed as 450

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IMA203, nivolumab plus relatlimab, or lifileucel. The registry lists allocation as randomized. This clinical trial is a prospective, multicenter, open-label, randomly assigned, actively controlled, parallel-group Phase 3 clinical trial to measure the how well it works, whether it is safe and how hard side effects are to live with 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 or mucosal melanoma (MM).

They plan to enroll about 450 people at 71 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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)

Interventions: IMA203, nivolumab plus relatlimab, lifileucel, nivolumab, pembrolizumab, ipilimumab, Dacarbazine, temozolomide, paclitaxel, paclitaxel plus carboplatin, Albumin-Bound Paclitaxel

Primary outcome (registry wording): Progression-free survival assessed by BICR

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Pathologically confirmed and documented cutaneous melanoma or mucosal melanoma. CM patients (including acral melanoma and melanoma of unknown primary) and mucosal melanoma patients with unresectable or metastatic disease
  • Positive for HLA-A\*02:01 or one of its P-group alleles
  • Adequate selected organ function per protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as this drug alone or in combination with other therapies as treatment for unresectable or metastatic melanoma
  • Life expectancy more than 6 months
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Public study contact (from the registry)

Immatics US, Inc.

+1 346 204-5400

ctgovinquiries@immatics.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

71 listed

+ 28 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06743126 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06743126?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06743126?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary