A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)
Summary
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/
Detailed description
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).
Arms & interventions
- BiologicalIMA203
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
- Biologicalnivolumab plus relatlimab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Biologicallifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Biologicalnivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Biologicalpembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Biologicalipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- DrugDacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Drugtemozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Drugpaclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- Drugpaclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
- DrugAlbumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Outcome measures
Primary
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
Secondary
Overall survival (OS)
Time frame: up to 5 years post first treatment of last patient
Objective response rate (ORR)
Time frame: up to 5 years post first treatment of last patient
Progression-free survival
Time frame: up to 5 years post first treatment of last patient
Treatment-emergent adverse events (TEAEs)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Adverse events of special interest (AESIs)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Treatment-emergent serious adverse events (TESAEs)
Time frame: until 85 days after cell therapy treatment or 30 days after last treatment
Frequency and duration of dose interruptions, reductions, and discontinuations
Time frame: up to 5 years post first treatment of last patient
EORTC QLQ-C30
Time frame: up to 5 years post first treatment of last patient
EQ-5D-5L
Time frame: up to 5 years post first treatment of last patient
Eligibility criteria
Study locations (40)
Mayo Clinic
Phoenix, Arizona, 85054
Honor Health Research Institute
Scottsdale, Arizona, 85258
City of Hope National Medical Center
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
UCLA Hematology/Oncology
Los Angeles, California, 90024
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Stanford Cancer Center
Stanford, California, 94305
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Yale Cancer Center
New Haven, Connecticut, 06510
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Miami - Sylvester Comprehensive Cancer Cente
Miami, Florida, 33136
Moffitt Cancer Center
Tampa, Florida, 33612
University of Chicago Medical Center
Chicago, Illinois, 60637
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Michigan
Ann Arbor, Michigan, 48109
Mayo Clinic
Rochester, Minnesota, 55905
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07960
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Rochester
Rochester, New York, 14642
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Lehigh Valley Topper Cancer Institute
Allentown, Pennsylvania, 18103
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Thomas Jeffersion University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
SCRI Oncology Partners
Nashville, Tennessee, 37203
Baylor University
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Virginia Commonwealth University
Richmond, Virginia, 23219
Fred Hutchinson Cancer Center
Seattle, Washington, 98109