Actively Recruiting
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Led by Immatics US, Inc. · Updated on 2026-04-21
360
Participants Needed
59
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed unresectable or metastatic cutaneous melanoma, including acral melanoma
- Positive for HLA-A*02:01
- Adequate organ function as defined by the study protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Disease progression on or after at least one PD-1 inhibitor treatment
- For patients with BRAF mutation, prior treatment with BRAF-directed therapy unless clinically not indicated
- Life expectancy greater than 6 months
- Measurable disease per RECIST 1.1 criteria
- Female patients of childbearing potential must use effective contraception from randomization until 12 months after IMA203 infusion or as per control treatment guidelines
- Male patients must agree to use effective contraception or abstain during the study and for 6 months after IMA203 infusion or as per control treatment guidelines
- Recovery to Grade 1 or lower from side effects of prior therapy before randomization
You will not qualify if you...
- Primary mucosal or uveal melanoma or melanoma of unknown primary origin
- History of other malignancies within last 3 years except adequately treated basal or squamous cell carcinoma or carcinoma in situ
- Serious autoimmune disease unless well controlled without immunosuppressive agents
- History of specific cardiac conditions as defined by protocol
- Prior allogenic stem cell or solid organ transplantation
- Severe or uncontrolled medical conditions that could affect study participation
- History or current immunodeficiency or treatments compromising immune function
- Hypersensitivity to cyclophosphamide, fludarabine, IL-2, or rescue medications
- Positive for HIV or active hepatitis B or C infection
- Conditions preventing leukapheresis
- Pregnant or breastfeeding
- Psychiatric disorders, substance dependence, or neurological impairments interfering with study
- Recent systemic corticosteroids, surgery, anti-cancer therapies, or investigational drugs before leukapheresis
- Active or reactivated infections
- Prior non-myeloablative lymphodepletion within 6 months
- Prior treatment with IMA203
- Ascites, pleural or pericardial effusion requiring repeated or continuous drainage
- Elevated LDH greater than 2.0 times the upper limit of normal
- Concurrent participation in interfering clinical or device trials
- Active brain or leptomeningeal metastases
- Recent investigational therapies, vaccines, corticosteroids, antibiotics, or anti-cancer treatments within specified timeframes
- Additional criteria as defined by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 59 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
UCLA Hematology/Oncology
Los Angeles, California, United States, 90024
Actively Recruiting
6
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
7
Stanford Cancer Center
Stanford, California, United States, 94305
Actively Recruiting
8
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
11
University of Miami - Sylvester Comprehensive Cancer Cente
Miami, Florida, United States, 33136
Actively Recruiting
12
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
13
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
14
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
15
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
16
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
17
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
19
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
20
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
21
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
22
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
23
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
24
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
25
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
26
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
27
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
28
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
Thomas Jeffersion University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
30
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
31
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
32
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
33
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
34
Baylor University
Dallas, Texas, United States, 75246
Actively Recruiting
35
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
36
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
37
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
38
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
39
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
40
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Active, Not Recruiting
41
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
42
Universitatsklinikum Koeln
Cologne, Northrhine-W Estphalia, Germany, 50937
Actively Recruiting
43
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany, 12203
Actively Recruiting
44
Universitaetsklinikum Bonn AöR
Bonn, Germany, 53127
Not Yet Recruiting
45
Technische Universitaet Dresden
Dresden, Germany, 01307
Actively Recruiting
46
Universitaetsklinikum Erlangen AöR
Erlangen, Germany, 91054
Actively Recruiting
47
Universitaetsklinikum Essen AöR
Essen, Germany, 45147
Actively Recruiting
48
Goethe University Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
49
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
50
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany, 69120
Actively Recruiting
51
Universitaet Leipzig
Leipzig, Germany, 04103
Actively Recruiting
52
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, 55131
Actively Recruiting
53
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
54
Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
55
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
56
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
57
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4GJ
Not Yet Recruiting
58
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Not Yet Recruiting
59
University of Southampton NHS Foundation Trust, Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
I
Immatics US, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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