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

NCT06743126 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IMA203-301
• Study Type: interventional
• Target: 360
• Locations: 4 countries
• Sites: 59

Brief 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/

Conditions

Melanoma, Cutaneous Malignant

Outcome Measures

Primary Outcomes (1)

• Progression-free survival assessed by BICR

  progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1

  up to 5 years post first treatment of last patient

Secondary Outcomes (9)

• Overall survival (OS)

  up to 5 years post first treatment of last patient

• Objective response rate (ORR)

  up to 5 years post first treatment of last patient

• Progression-free survival

  up to 5 years post first treatment of last patient

• Treatment-emergent adverse events (TEAEs)

  until 85 days after cell therapy treatment or 30 days after last treatment

• Adverse events of special interest (AESIs)

  until 85 days after cell therapy treatment or 30 days after last treatment

Study Arms (2)

Experimental arm

EXPERIMENTAL

Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), 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

Biological: IMA203

Control arm- investigator's choice

ACTIVE COMPARATOR

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), optional bridging therapy.

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

Interventions

nivolumab plus relatlimab BIOLOGICAL

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Opdualag®

Control arm- investigator's choice

IMA203 BIOLOGICAL

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

Also known as: anzutresgene autoleucel, anzu-cel

Experimental arm

lifileucel BIOLOGICAL

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: AMTAGVI

Control arm- investigator's choice

nivolumab BIOLOGICAL

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Opdivo®

Control arm- investigator's choice

pembrolizumab BIOLOGICAL

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Keytruda®

Control arm- investigator's choice

ipilimumab BIOLOGICAL

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Yervoy

Control arm- investigator's choice

Dacarbazine DRUG

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: DTIC-Dome

Control arm- investigator's choice

temozolomide DRUG

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Temodar

Control arm- investigator's choice

paclitaxel DRUG

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Taxol

Control arm- investigator's choice

paclitaxel plus carboplatin DRUG

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Carbo/Taxol®

Control arm- investigator's choice

Albumin-Bound Paclitaxel DRUG

in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)

Also known as: Abraxane®

Control arm- investigator's choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) 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.

You may not qualify if:

• Primary mucosal or uveal melanoma and melanoma of unknown primary
• 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,

Sponsors & Collaborators

• Immatics US, Inc.: lead

Study Sites (59)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

UCLA Hematology/Oncology

Los Angeles, California, 90024, United States

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

RECRUITING

Stanford Cancer Center

Stanford, California, 94305, United States

RECRUITING

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

ACTIVE NOT RECRUITING

University of Miami - Sylvester Comprehensive Cancer Cente

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of MD Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

RECRUITING

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jeffersion University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Baylor University

Dallas, Texas, 75246, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

ACTIVE NOT RECRUITING

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Universitatsklinikum Koeln

Cologne, Northrhine-W Estphalia, 50937, Germany

RECRUITING

Charite Universitaetsmedizin Berlin KöR

Berlin, 12203, Germany

RECRUITING

Universitaetsklinikum Bonn AöR

Bonn, 53127, Germany

NOT YET RECRUITING

Technische Universitaet Dresden

Dresden, 01307, Germany

RECRUITING

Universitaetsklinikum Erlangen AöR

Erlangen, 91054, Germany

RECRUITING

Universitaetsklinikum Essen AöR

Essen, 45147, Germany

RECRUITING

Goethe University Frankfurt

Frankfurt am Main, 60590, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitaetsklinikum Heidelberg AöR

Heidelberg, 69120, Germany

RECRUITING

Universitaet Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, 55131, Germany

RECRUITING

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

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

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

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

London, SE1 9RT, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4GJ, United Kingdom

NOT YET RECRUITING

Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

NOT YET RECRUITING

University of Southampton NHS Foundation Trust, Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma, Cutaneous Malignant

Interventions

Nivolumab; relatlimab; Opdualag; lifileucel; pembrolizumab; Ipilimumab; Dacarbazine; Temozolomide; Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Coordination Complexes; Albumins

Study Officials

• Cedrik Britten, M.D.

  Immatics US, Inc.

  STUDY DIRECTOR

Central Study Contacts

Immatics US, Inc.

CONTACT

+1 346 204-5400; ctgovinquiries@immatics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 19, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

GB (7); DE (11); CA (2); US (39)