ClinicaliQ Trial Snapshot
- SUPRAME-ACTengine® IMA203 vs. Investigator’s Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma — Recruiting • Phase III • Oncology • NCT06743126.
- Treatment Being Tested: IMA203, a novel immunotherapy agent, is being compared against investigator's choice of standard treatments (such as checkpoint inhibitors or chemotherapy) in patients with advanced cutaneous melanoma who have already received prior treatment.
- Patient Eligibility Overview: The trial enrolls patients with previously treated, unresectable or metastatic cutaneous melanoma, meaning those whose disease has progressed despite earlier therapies and cannot be surgically removed or has spread systemically.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) 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 * Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma * Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.