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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics US, Inc.

About this trial

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/

Eligibility criteria

Qualifiers

Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease

HLA-A*02:01 positive

Adequate selected organ function per protocol

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Disqualifiers

Primary mucosal or uveal melanoma

History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years

Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.

History of cardiac conditions as per protocol

Trial design

Treatments tested in this trial

  • IMA203
  • nivolumab plus relatlimab
  • lifileucel
  • nivolumab
  • pembrolizumab
  • ipilimumab
  • Dacarbazine
  • temozolomide
  • paclitaxel
  • paclitaxel plus carboplatin
  • Albumin-Bound Paclitaxel

Treatment groups

360 Participants
are divided into 2 treatment groups

Sponsors and collaborators