IMA203-301 is a prospective, multi-center, open-label, randomized, actively controlled, parallel-group Phase 3 trial to evaluate the efficacy, safety, and tolerability of treatment with IMA203 administered at the RP2D compared vs. investigator’s choice of treatment in HLA-A*02:01-positive patients with previously treated, unresectable or metastatic CM.

Who can Participate

Inclusion: -Patients must have pathologically confirmed and documented cutaneous melanoma (CM) patients with unresectable or metastatic (= advanced) disease. -Unresectable or metastatic CM patients who must have confirmed (VB) disease progression on or after at least one PD-1 inhibitor either as monotherapy or in combination with other therapies [except for PRAME-directed therapies] applied as treatment for advanced disease. Patients should be considered for anti-PD-1/anti-CTLA-4 combination therapy prior to initial eligibility assessment. -Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy Exclusion: -History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years -Primary mucosal or uveal melanoma More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.

Study ID

More information available at ClinicalTrials.gov: NCT06743126