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 stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. TREATMENT- Control arm: Investigator's choice of treatment approved by the respective competent authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
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)
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGHonor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
Progression-free survival assessed by BICR
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
Time frame: up to 5 years post first treatment of last patient
Overall survival (OS)
conducted onsite or can be performed by phone
Time frame: up to 5 years post first treatment of last patient
Objective response rate (ORR)
complete responses (CR) and partial response (PR) based on best overall response (BOR), locally and centrally (by blinded independent central review) assessed using RECIST 1.1
Time frame: up to 5 years post first treatment of last patient
Progression-free survival
Progression-free survival locally assessed using RECIST 1.1
Time frame: up to 5 years post first treatment of last patient
Treatment-emergent adverse events (TEAEs)
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Adverse events of special interest (AESIs)
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Treatment-emergent serious adverse events (TESAEs)
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Frequency and duration of dose interruptions, reductions, and discontinuations
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
Time frame: up to 5 years post first treatment of last patient
EORTC QLQ-C30
To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)
Time frame: up to 5 years post first treatment of last patient
EQ-5D-5L
To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)
Time frame: up to 5 years post first treatment of last patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCLA Hematology/Oncology
Los Angeles, California, United States
RECRUITINGUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGStanford Cancer Center
Stanford, California, United States
RECRUITINGUniversity of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITING...and 56 more locations