SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT ID: NCT06743126
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2025-01-14
2031-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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.
nivolumab plus relatlimab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
lifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
nivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
pembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
ipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Dacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
temozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Albumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Interventions
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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
nivolumab plus relatlimab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
lifileucel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
nivolumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
pembrolizumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
ipilimumab
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Dacarbazine
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
temozolomide
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
paclitaxel plus carboplatin
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Albumin-Bound Paclitaxel
in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Immatics US, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cedrik Britten, M.D.
Role: STUDY_DIRECTOR
Immatics US, Inc.
Locations
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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
Yale Cancer Center
New Haven, Connecticut, 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 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
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
Charite Universitaetsmedizin Berlin KöR
Berlin, , Germany
Universitaetsklinikum Bonn AöR
Bonn, , Germany
University Hospital Cologne AöR
Cologne, , 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
Countries
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Central Contacts
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Facility Contacts
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Michael Hurwitz, MD, PhD
Role: primary
Lilit Karapetyan, MD, MS, FACP
Role: primary
Alexandra (Lexi) Haugh, MD, MPH
Role: primary
Eric Whiteman, MD
Role: primary
Richard Wu, MD, PhD
Role: primary
Tara Mitchell, MD
Role: primary
Meredith A McKean, MD, MPH
Role: primary
Charles (Lance) Cowey, MD
Role: primary
Antonia Busse, MD
Role: primary
Martin Wermke, MD
Role: primary
Carola Berking, MD
Role: primary
Dirk Schadendorf, MD
Role: primary
Bastian Schilling, MD
Role: primary
Christoffer Gebhardt, MD
Role: primary
Jessica Hassel, MD
Role: primary
Jan Simon, MD
Role: primary
Eva Maria Wagner-Drouet, MD
Role: primary
Other Identifiers
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IMA203-301
Identifier Type: -
Identifier Source: org_study_id
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