SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Start Date
1/14/2025
Completion Date
10/1/2031
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IMA203
nivolumab plus relatlimab
lifileucel
nivolumab
pembrolizumab
ipilimumab
Dacarbazine
temozolomide
paclitaxel
paclitaxel plus carboplatin
Albumin-Bound Paclitaxel
Conditions
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
City of Hope National Medical Center
Duarte, California 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
UCLA Hematology/Oncology
Los Angeles, California 90024
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94143
United States
Stanford Cancer Center
Stanford, California 94305
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado 80045
United States
Yale Cancer Center
New Haven, Connecticut 06510
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
University of Miami - Sylvester Comprehensive Cancer Cente
Miami, Florida 33136
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey 07960
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44195
United States
Ohio State University
Columbus, Ohio 43210
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United States
Lehigh Valley Topper Cancer Institute
Allentown, Pennsylvania 18103
United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jeffersion University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Baylor University
Dallas, Texas 75246
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
Virginia Commonwealth University
Richmond, Virginia 23219
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
BC Cancer - Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Centre Hospitalier Universitaire De Lille
Lille, 59000
France
Assistance Publique Hopitaux De Paris, Hôpital Saint Louis
Paris, 75010
France
Institut Gustave Roussy
Villejuif, 94800
France
Universitatsklinikum Koeln
Cologne, Northrhine-W Estphalia 50937
Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 12203
Germany
Universitaetsklinikum Bonn AöR
Bonn, 53127
Germany
Technische Universitaet Dresden
Dresden, 01307
Germany
Universitaetsklinikum Erlangen AöR
Erlangen, 91054
Germany
Universitaetsklinikum Essen AöR
Essen, 45147
Germany
Goethe University Frankfurt
Frankfurt am Main, 60590
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitaetsklinikum Heidelberg AöR
Heidelberg, 69120
Germany
Universitaet Leipzig
Leipzig, 04103
Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, 55131
Germany
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Amsterdam, 1066 CX
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, 3015 GD
Netherlands
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center
Glasgow, G12 0YN
United Kingdom
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London, SE1 9RT
United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4GJ
United Kingdom
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford, OX3 7LE
United Kingdom
University of Southampton NHS Foundation Trust, Southampton General Hospital
Southampton, SO16 6YD
United Kingdom