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Melanoma, Cutaneous MalignantPhase 3SUPRAMENCT06743126

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

A Phase 3 study testing IMA203, nivolumab plus relatlimab and lifileucel in people with Melanoma, Cutaneous Malignant and Mucosal Melanoma, run by Immatics US, Inc. at 71 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMA203, nivolumab plus relatlimab and lifileucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
71 sitesin 6 countries
Study dates
14 Jan 2025to 12 Aug 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed and documented cutaneous melanoma or mucosal melanoma. CM patients (including acral melanoma and melanoma of unknown primary) and mucosal melanoma patients with unresectable or metastatic disease
  • Positive for HLA-A*02:01 or one of its P-group alleles
  • 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 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

71 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Immatics US, Inc. contact

+1 346 204-5400

ctgovinquiries@immatics.com

71 sites in 6 countries

United States43 sites, 43 recruiting

  • Lehigh Valley Topper Cancer Institute

    Allentown, Pennsylvania, 18103

    Rino Seedor, MD, 215-847-7409, Rino.Seedor@jefferson.edu

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Leslie Fecher, MD, 734-647-8921, lfecher@med.umich.edu

    Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Nathaniel Wilson, MD

    Recruiting

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado, 80045

    Sapna Patel, MD, 720-848-0000

    Recruiting

  • University of MD Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Petra Hausner, MD, PhD, 410-328-2567, phausner@umm.edu

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Alexandra (Lexi) Haugh, MD, MPH

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    David McDermott, MD, dmcdermo@bidmc.harvard.edu

    Recruiting

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Stergios Moschos, MD, 919-843-7713, stergios_moschos@med.unc.edu

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Daniel Olson, MD, dolson2@medicine.bsd.uchicago.edu

    Recruiting

  • Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio, 44195

    James Isaac, isaacsj3@ccf.org

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Richard Wu, MD, PhD

    Recruiting

  • Baylor University

    Dallas, Texas, 75246

    Charles (Lance) Cowey, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Sanjay Chandrasekaran, MD, Sanjay.Chandrasekaran@utsouthwestern.edu

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Yan Xing, MD, yxing@coh.org

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Rodabe N Amaria, MD, 346-723-9626, RNAmaria@mdanderson.org

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Ruqin Chen, MD, chen.ruqin@mayo.edu

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Gregory Daniels, MD, gdaniels@health.ucsd.edu

    Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California, 90024

    Bartosz Chmielowski, MD, PhD, bchmielowski@mednet.ucla.edu

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Vincent Ma, MD

    Recruiting

  • University of Miami - Sylvester Comprehensive Cancer Cente

    Miami, Florida, 33136

    Leonel Hernandez-Aya, MD, l.hernandezaya@med.miami.edu

    Recruiting

  • Atlantic Health System/Morristown Medical Center

    Morristown, New Jersey, 07960

    Eric Whitman, MD, eric.whitman@atlantichealth.org

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Meredith A McKean, MD, MPH, 615-524-4461

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Michael Hurwitz, MD, PhD

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Maya Dimitrova, MD, 212-731-6230, maya.dimitrova@nyulangone.org

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    James Smithy, MD, smithyj@mskcc.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Bhavina Sharma, MD, 402-559-5692, bhsharma@unmc.edu

    Recruiting

  • AdventHealth, Orlando

    Orlando, Florida, 32804

    Sajeve Thomas, MD

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Tara Mitchell, MD, 215-662-7908

    Recruiting

  • Thomas Jeffersion University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

    Rino Seedor, MD, 215-847-7409, Rino.Seedor@jefferson.edu

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Anthony J Olszanski, MD, RPh, 215-728-5673, Anthony.Olszanski@FCCC.edu

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Seetharam Mahesh, MD, Seetharam.Mahesh@mayo.edu

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Diwakar Davar, M.D., 412-623-7368, davard@upmc.edu

    Jason J Luke, M.D.

    Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

    Matthew Taylor, MD, Matthew.Taylor@providence.org

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

    Andrew Poklepovic, MD, andrew.poklepovic@vcuhealth.org

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Arkadiusz Dudek, MD, PhD, dudek.arkadiusz@mayo.edu

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Sahasrabudhe Deepak, MD, deepak_sahasrabudhe@urmc.rochester.edu

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Siwen Hu-Lieskovan, MD, PhD, Siwen.Hu-Leiskovan@hci.utah.edu

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

    Adil Daud, MD, adil.daud@ucsf.edu

    Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

    Justin Moser, MD, 480-583-7219, jmoser@honorhealth.com

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Sylvia Lee, MD, leesm@uw.edu

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Benjamin Solomon, MD, 605-322-6900, Benjamin.Solomon@avera.org

    Recruiting

  • Stanford Cancer Center

    Stanford, California, 94305

    Alison Betof Warner, MD, PhD, allison.betof@stanford.edu

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Lilit Karapetyan, MD, MS, FACP

    Recruiting

Other trials in United States

Germany11 sites, 11 recruiting

  • Charite Universitaetsmedizin Berlin KöR

    Berlin, 12203

    Recruiting

  • Universitaetsklinikum Bonn AöR

    Bonn, 53127

    Recruiting

  • Universitatsklinikum Koeln

    Cologne, Northrhine-W Estphalia, 50937

    Recruiting

  • Technische Universitaet Dresden

    Dresden, 01307

    Recruiting

  • Universitaetsklinikum Erlangen AöR

    Erlangen, 91054

    Recruiting

  • Universitaetsklinikum Essen AöR

    Essen, 45147

    Recruiting

  • Goethe University Frankfurt

    Frankfurt am Main, 60590

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitaetsklinikum Heidelberg AöR

    Heidelberg, 69120

    Recruiting

  • Universitaet Leipzig

    Leipzig, 04103

    Recruiting

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    Mainz, 55131

    Recruiting

Other trials in Germany

United Kingdom7 sites, 7 recruiting

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

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

    Glasgow, G12 0YN

    Recruiting

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

    London, SE1 9RT

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4GJ

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

  • University of Southampton NHS Foundation Trust, Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

Other trials in United Kingdom

Canada4 sites, 4 recruiting

  • Cross Cancer Institute, Alberta

    Edmonton, Alberta, T6G 1Z2

    Matthew Anaka, MD

    Recruiting

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

    Rahima Jamal, MD

    Recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Marcus Butler, MD, Marcus.Butler@uhn.ca

    Recruiting

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Alison Weppler, MD, 607-877-6000, alison.weppler@phsa.ca

    Recruiting

Other trials in Canada

France3 sites, 3 recruiting

  • Centre Hospitalier Universitaire De Lille

    Lille, 59000

    Recruiting

  • Assistance Publique Hopitaux De Paris, Hôpital Saint Louis

    Paris, 75010

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Netherlands3 sites, 3 recruiting

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

    Amsterdam, 1066 CX

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    Rotterdam, 3015 GD

    Recruiting

Other trials in Netherlands

About this study

Official title: 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 or mucosal melanoma (MM).

For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/

Read the 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 positive HLA-A*02:01 or one of its P-group alleles 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 T-cell infusion will be administered at an authorized treatment center.

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).

Being tested
IMA203, nivolumab plus relatlimab, lifileucel, nivolumab, pembrolizumab
Medical subject headings
Melanoma, Cutaneous Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMA203Biological

    Also called anzutresgene autoleucel, anzu-cel

    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 relatlimabBiological

    Also called Opdualag®

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

  • lifileucelBiological

    Also called AMTAGVI

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

  • nivolumabBiological

    Also called Opdivo®

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

  • pembrolizumabBiological

    Also called Keytruda®

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

  • ipilimumabBiological

    Also called Yervoy

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

  • DacarbazineDrug

    Also called DTIC-Dome

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

  • temozolomideDrug

    Also called Temodar

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

  • paclitaxelDrug

    Also called Taxol

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

  • paclitaxel plus carboplatinDrug

    Also called Carbo/Taxol®

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

  • Albumin-Bound PaclitaxelDrug

    Also called Abraxane®

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

Study groups in NCT06743126
Study groupRoleWhat they receive
Experimental armExperimentalNon-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
Receives: Biological: IMA203
Control arm- investigator's choiceActive comparatorInvestigator'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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival assessed by BICR

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

    Measured: up to 5 years post first treatment of last patient

Secondary outcomes (9)

  1. Overall survival (OS)

    conducted onsite or can be performed by phone

    Measured: up to 5 years post first treatment of last patient

  2. Objective response rate (ORR)

    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

    Measured: up to 5 years post first treatment of last patient

  3. Progression-free survival

    Progression-free survival locally assessed using RECIST 1.1

    Measured: up to 5 years post first treatment of last patient

  4. Treatment-emergent adverse events (TEAEs)

    To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)

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

  5. Adverse events of special interest (AESIs)

    To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)

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

  6. Treatment-emergent serious adverse events (TESAEs)

    To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)

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

  7. Frequency and duration of dose interruptions, reductions, and discontinuations

    To evaluate safety and tolerability of treatment with IMA203 compared with control (investigator's choice)

    Measured: up to 5 years post first treatment of last patient

  8. EORTC QLQ-C30

    To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)

    Measured: up to 5 years post first treatment of last patient

  9. EQ-5D-5L

    To evaluate the patient-reported quality of life before and after treatment with IMA203 compared with control (investigator's choice)

    Measured: up to 5 years post first treatment of last patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start14 Jan 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completion12 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743126
Sponsor's protocol ID
IMA203-301
Acronym
SUPRAME
Status last verified
Oct 2026
First submitted
11 Dec 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMA203, nivolumab plus relatlimab and lifileucel in people with Melanoma, Cutaneous Malignant and Mucosal Melanoma, run by Immatics US, Inc. at 71 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Germany, United Kingdom, Canada, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Immatics US, Inc. (+1 346 204-5400, ctgovinquiries@immatics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival assessed by BICR (time frame: up to 5 years post first treatment of last patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06743126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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