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