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RecruitingPhase 3NCT06743126

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

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)

Sponsor

Immatics US, Inc.

Enrollment

360 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma, Cutaneous Malignant

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/

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SUPRAME) compares a personalized cell therapy called IMA203 (which uses a patient's own immune cells, re-engineered to attack a cancer protein called PRAME) against the doctor's standard treatment choice for people with advanced or metastatic melanoma that has progressed after immunotherapy. **You may be eligible if...** - You have confirmed unresectable or metastatic skin melanoma - Your tumor tests positive for a specific immune marker called HLA-A*02:01 - Your melanoma has progressed after at least one PD-1 immunotherapy - If your melanoma has a BRAF mutation, you have also received a BRAF-targeted therapy - You have measurable disease and a life expectancy of more than 6 months **You may NOT be eligible if...** - Your melanoma started in mucous membranes (mouth, genital area) or the eye - You have had another cancer in the past 3 years - You have active brain metastases - You have severe autoimmune disease or immunodeficiency - You have had a prior organ transplant or stem cell transplant - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Locations(59)

Mayo Clinic

Phoenix, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Stanford Cancer Center

Stanford, California, United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Cente

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of MD Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Thomas Jeffersion University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Baylor University

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Universitatsklinikum Koeln

Cologne, Northrhine-W Estphalia, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

Universitaetsklinikum Bonn AöR

Bonn, Germany

Technische Universitaet Dresden

Dresden, Germany

Universitaetsklinikum Erlangen AöR

Erlangen, Germany

Universitaetsklinikum Essen AöR

Essen, Germany

Goethe University Frankfurt

Frankfurt am Main, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg AöR

Heidelberg, Germany

Universitaet Leipzig

Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, Germany

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

Cambridge, United Kingdom

Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center

Glasgow, United Kingdom

Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

Oxford, United Kingdom

University of Southampton NHS Foundation Trust, Southampton General Hospital

Southampton, United Kingdom

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NCT06743126