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NCT06743126PHASE3Recruiting

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

Immatics US, Inc.

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

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 treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization and prior to trial treatment start. Exclusion Criteria: * Primary mucosal or uveal melanoma * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents. * History of cardiac conditions as per protocol * Prior allogenic stem cell transplantation or solid organ transplantation * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician * History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs * Known hypersensitivity to any of the rescue medications * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Any condition contraindicating leukapheresis * Pregnant or breastfeeding * Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment) * Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis, * Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis. * Patients with any active infection or ongoing reactivation of infection * Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months * Prior treatment with IMA203 * Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months * Patients with LDH greater than 2.0-fold ULN * Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment * Patients with active brain metastases or leptomeningeal metastases * Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization * Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment * Other protocol defined inclusion/exclusion criteria could apply

Interventions

BIOLOGICAL

IMA203

BIOLOGICAL

nivolumab plus relatlimab

BIOLOGICAL

lifileucel

BIOLOGICAL

nivolumab

BIOLOGICAL

pembrolizumab

BIOLOGICAL

ipilimumab

DRUG

Dacarbazine

DRUG

temozolomide

DRUG

paclitaxel

DRUG

paclitaxel plus carboplatin

DRUG

Albumin-Bound Paclitaxel

Interested in This Trial?

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Conditions

Melanoma, Cutaneous Malignant

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