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

June 8, 2026 updated by: Immatics US, Inc.

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)

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/

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Active, not recruiting
        • BC Cancer - Vancouver
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Cancer Centre
        • Contact:
  • France
      • Lille, France, 59000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Lille
      • Paris, France, 75010
        • Not yet recruiting
        • Assistance Publique Hopitaux De Paris, Hôpital Saint Louis
      • Villejuif, France, 94800
        • Not yet recruiting
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charite Universitaetsmedizin Berlin KöR
        • Contact:
          • Antonia Busse, MD
      • Bonn, Germany, 53127
        • Not yet recruiting
        • Universitaetsklinikum Bonn AöR
        • Contact:
          • Tobias Holderried, MD
      • Dresden, Germany, 01307
        • Recruiting
        • Technische Universitaet Dresden
        • Contact:
          • Martin Wermke, MD
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen AöR
        • Contact:
          • Carola Berking, MD
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen AöR
        • Contact:
          • Dirk Schadendorf, MD
      • Frankfurt am Main, Germany, 60590
        • Recruiting
        • Goethe University Frankfurt
        • Contact:
          • Bastian Schilling, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
          • Christoffer Gebhardt, MD
      • Heidelberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg AöR
        • Contact:
          • Jessica Hassel, MD
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitaet Leipzig
        • Contact:
          • Jan Simon, MD
          • Phone Number: 493419718600
      • Mainz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
        • Contact:
          • Eva Maria Wagner-Drouet, MD
    • Northrhine-W Estphalia
      • Cologne, Northrhine-W Estphalia, Germany, 50937
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Not yet recruiting
        • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Not yet recruiting
        • Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center
      • London, United Kingdom, SW3 6JJ
        • Not yet recruiting
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
      • Manchester, United Kingdom, M20 4GJ
        • Not yet recruiting
        • The Christie NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Not yet recruiting
        • University of Southampton NHS Foundation Trust, Southampton General Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health Research Institute
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90024
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Contact:
      • Stanford, California, United States, 94305
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado, Anschutz Medical Campus
        • Contact:
          • Sapna Patel, MD
          • Phone Number: 720-848-0000
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
        • Contact:
          • Michael Hurwitz, MD, PhD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • Mayo Clinic Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami - Sylvester Comprehensive Cancer Cente
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Lilit Karapetyan, MD, MS, FACP
    • Illinois
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of MD Greenebaum Comprehensive Cancer Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Alexandra (Lexi) Haugh, MD, MPH
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Hospitals, The University of North Carolina at Chapel Hill
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic, Taussig Cancer Institute
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
          • Richard Wu, MD, PhD
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Active, not recruiting
        • Lehigh Valley Topper Cancer Institute
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, Abramson Cancer Center
        • Contact:
          • Tara Mitchell, MD
          • Phone Number: 215-662-7908
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jeffersion University, Sidney Kimmel Cancer Center
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Principal Investigator:
          • Jason J Luke, M.D.
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Contact:
          • Meredith A McKean, MD, MPH
          • Phone Number: 615-524-4461
    • Texas
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University
        • Contact:
          • Charles (Lance) Cowey, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Virginia
      • Richmond, Virginia, United States, 23219
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
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
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
Other Names:
  • anzutresgene autoleucel
  • anzu-cel
Active Comparator: Control arm- investigator's choice
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
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Opdualag®
Biological: lifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • AMTAGVI
Biological: nivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Opdivo®
Biological: pembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Keytruda®
Biological: ipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Yervoy
Drug: Dacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • DTIC-Dome
Drug: temozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Temodar
Drug: paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Taxol
Drug: paclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Carbo/Taxol®
Drug: Albumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Names:
  • Abraxane®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival assessed by BICR
Time Frame: up to 5 years post first treatment of last patient
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 5 years post first treatment of last patient
conducted onsite or can be performed by phone
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
complete responses (CR) and partial response (PR) based on best overall response (BOR), locally and centrally (by blinded independent central review) assessed using RECIST 1.1
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
Progression-free survival locally assessed using RECIST 1.1
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
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
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
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
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
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
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
To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)
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
To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)
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
To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)
up to 5 years post first treatment of last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immatics US, Inc.

Investigators

  • Study Director: Cedrik Britten, M.D., Immatics US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMA203-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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