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 91 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
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 450
- Started
- 2025-01-14
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for melanoma, cutaneous malignant
- • Phase3 - 450 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 or mucosal melanoma (MM)
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 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/
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 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).
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
- ✓Positive for HLA-A\*02:01 or one of its P-group alleles
- ✓Adequate selected organ health per protocol
- ✓activity scale (ECOG) performance status 0-1
- ✓Life expectancy more than 6 months
- ✓cancer that can be measured on scans according to Response Evaluation Criteria in Solid Tumors ((standard scan measurements))
Who cannot take part
- ✗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
