Immatics US, Inc.
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/
SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening. Leukapheresis for potential manufacturing of the IMA203 cellular product may be performed, if patients are HLA-A\*02:01 positive and meet the eligibility criteria for leukapheresis. MANUFACTURING: IMA203 products will be made from the patients' white blood cells. TREATMENT- Experimental arm: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product…
Inclusion Criteria: * 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 * 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 tr…
one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)