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Looking for participantsPhase3

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

Sponsor: Immatics US, Inc.

NCT ID: NCT06743126

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
IMA203 (biological), nivolumab plus relatlimab (biological), lifileucel (biological), nivolumab (biological)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
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 · nivolumab plus relatlimab — biological: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · lifileucel — biological: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · nivolumab — biological: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · pembrolizumab — biological: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · ipilimumab — biological: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · Dacarbazine — drug: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · temozolomide — drug: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · paclitaxel — drug: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · paclitaxel plus carboplatin — drug: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) · Albumin-Bound Paclitaxel — drug: in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)
Patient visit burden
Not specified by the sponsor

In plain English

This trial compares a treatment called IMA203 (also known as SUPRAME-ACTengine) with a treatment chosen by the doctor, called 'investigator's choice'. It is for people with skin melanoma that cannot be removed by surgery or has spread to other parts of the body, and that got worse despite earlier treatment. The sponsor is Immatics US, Inc.

Who can take part

  • Confirmed cutaneous melanoma (skin melanoma, including acral melanoma and melanoma of unknown primary) that cannot be removed by surgery or has spread
  • Positive for a tissue marker called HLA-A*02:01
  • Good working of certain organs, as set out in the trial rules
  • Able to carry out day-to-day activities with little or no help (performance status 0 to 1 on a scale used by doctors)
  • The cancer got worse or caused bad side effects during or after at least one treatment with a PD-1 inhibitor (a type of immunotherapy), given alone or with other treatments
  • If you have a BRAF mutation, you should usually have had one previous treatment targeting BRAF (with or without a MEK inhibitor), unless the doctor decides it was not suitable or you declined it
  • Expected to live more than 6 months
  • Cancer that can be measured on scans using standard rules called RECIST 1.1
  • Women who can become pregnant, and men, must agree to use contraception or be abstinent during the trial and for a set time afterwards
  • Recovered from side effects of previous cancer treatment before joining the trial

Who may not be able to

  • Melanoma that started in moist body surfaces (mucosal) or in the eye (uveal)
  • Another cancer in the last 3 years, apart from some treated skin cancers
  • Serious autoimmune disease, unless well controlled without drugs that dampen the immune system
  • Certain heart conditions, as set out in the trial rules
  • Past stem cell transplant from a donor, or a solid organ transplant
  • Other severe or uncontrolled illness that could affect taking part
  • History of a weakened immune system or treatment that harms immune function
  • Allergy to CY, FLU, or IL-2, or to rescue medicines, or any reason the chosen standard treatment is not safe
  • HIV, or active hepatitis B or C infection
  • Any condition that makes leukapheresis (a procedure to collect white blood cells) unsafe
  • Pregnant or breastfeeding
  • Steroid medicine by mouth or injection within 2 weeks before leukapheresis
  • Surgery, other cancer treatment, marrow-suppressing drugs, or experimental drugs within 7 days before leukapheresis
  • An active infection or an infection that has come back
  • Lymphodepletion (a treatment that lowers white blood cells) before cell therapy in the last 6 months
  • Previous treatment with IMA203
  • Fluid build-up (in the belly, around the lungs, or around the heart) needing repeated drainage in the last 2 months
  • LDH (a blood test) more than twice the normal upper limit
  • Taking part in another trial of a drug or device at the same time
  • Active cancer spread to the brain or the tissues around the brain and spinal cord
  • Experimental treatments, certain vaccines, long-term steroids, or antibiotics into a vein within 1 week before joining, or live vaccines within 4 weeks
  • Any cancer treatment or radiotherapy within 1 week before the trial treatment starts
  • Other reasons set out in the trial rules may also apply

What taking part involves

  • • You are given either IMA203 or a treatment chosen by your doctor (the 'investigator's choice')
  • • IMA203 is made from your own white blood cells, collected through a procedure called leukapheresis
  • • Not stated — ask the trial team about the full details of how each treatment is given

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the trial lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
360
Started
2025-01-14
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for melanoma, cutaneous malignant
  • • Phase3 - 360 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with melanoma, cutaneous malignant

Where?

  • • Cambridge - Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
  • • Glasgow - Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center
  • • London - Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
  • • London - The Royal Marsden NHS Foundation Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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/

More detail

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).

Melanoma, Cutaneous Malignant

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

01 positiveBRAF

Treatment history

Treatments you must have had:

  • ✓ of BRAF-directed therapy (with
  • ✓ recovered from any side effects of prior therapy to Grade 1 or lower
  • ✓ to Grade 1

What the study is looking for

  • ✓Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of...
  • ✓HLA-A\*02:01 positive
  • ✓Adequate selected organ health per protocol
  • ✓activity scale (ECOG) performance status 0-1
  • ✓Life expectancy more than 6 months

Who cannot take part

  • ✗Primary mucosal or uveal melanoma
  • ✗History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ)...
  • ✗Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their...
  • ✗History of heart conditions as per protocol
  • ✗Prior allogenic stem cell transplantation or solid organ transplantation
See the full criteria
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

Where Is This Study? (7 UK sites)

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

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

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

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

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Christie NHS Foundation Trust

Manchester M20 4GJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

University of Southampton NHS Foundation Trust, Southampton General Hospital

Southampton SO16 6YD, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Immatics US, Inc.

Sponsor contact

CONTACT

+1 346 204-5400 ctgovinquiries@immatics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06