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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (7 UK sites)
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center
Glasgow G12 0YN, United Kingdom
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London SE1 9RT, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4GJ, United Kingdom
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford OX3 7LE, United Kingdom
University of Southampton NHS Foundation Trust, Southampton General Hospital
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Immatics US, Inc.
Sponsor contactCONTACT
