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
- Brenetafusp (drug), Nivolumab (drug), Nivolumab + Relatlimab (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Brenetafusp — drug: Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL. · Nivolumab — drug: Concentrate for solution for infusion at a unit dose of 10 mg/mL. · Nivolumab + Relatlimab — drug: Concentrate for solution for infusion at a unit dose of 16 mg/mL.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called PRISM-MEL-301, is for people with advanced melanoma (stage III that cannot be removed by surgery, or stage IV) that has not been treated before with whole-body cancer drugs. It compares a treatment called IMC-F106C against treatment regimens containing nivolumab. The study is run by Immunocore Ltd.
Who can take part
- You have a tissue marker called HLA-A*02:01 (a blood test can show this)
- Your melanoma is confirmed by looking at tissue under a microscope, and is either stage IV or stage III that cannot be removed by surgery
- You can provide a tumour tissue sample (stored or new) that is suitable for testing
- Your cancer can be measured on scans using standard guidelines (RECIST 1.1)
- Your BRAF gene mutation status is known (a test on your tumour)
- You are well enough for everyday activity (performance status score of 0 or 1)
- If you or your partner could have children, you agree to use highly effective contraception from screening until 5 months after the last study dose
Who may not be able to
- You have had another cancer in the past (other than the one being treated in this study)
- You have untreated, active or symptom-causing cancer spread to the brain or spinal cord, or cancer in the linings around the brain
- You are allergic to IMC-F106C, nivolumab, relatlimab or any of their ingredients
- You have serious lung disease or reduced lung function
- You have serious heart disease or reduced heart function
- You have an active autoimmune disease needing treatment that suppresses the immune system
- You have another poorly controlled medical condition that the study doctor or sponsor believes would make taking part unsafe or affect the study results
- You have already had whole-body (systemic) treatment for melanoma that has spread or cannot be removed
- You have had a life-threatening reaction to previous treatment with anti-PD-(L)1 or anti-LAG-3 drugs
What taking part involves
- • You would receive either the IMC-F106C treatment or a treatment regimen containing nivolumab (a type of immunotherapy) — how the drugs are given and how often is not stated, so ask the trial team
- • The study is comparing these treatments to see how well they work — details of tests and scans are not stated; ask the trial team
Time commitment: Number of visits, study duration and what taking part day-to-day involves are not stated — ask the trial team; if you or a partner could have children, contraception is needed until 5 months after your last study dose.
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
- 680
- Started
- 2024-06-05
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for advanced melanoma
- • Phase3 - 680 participants
- • This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced melanoma
Where?
- • Birmingham - Queen Elizabeth Hospital Birmingham
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
- • Glasgow - Beatson West of Scotland Cancer Centre
- • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
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:
- ✓ histologically confirmed Stage IV or unresectable Stage III melanoma
- ✓ measurable disease per RECIST 1
- ✓ BRAF V600 mutation status determined
- ✓ an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
What the study is looking for
- ✓Participants must be HLA-A\*02:01-positive
- ✓Participants must have confirmed by a biopsy Stage IV or unresectable Stage III melanoma
- ✓Archived or fresh tumor tissue sample that must be confirmed as adequate
- ✓Participants must have cancer that can be measured on scans 1.1
- ✓Participant must have BRAF V600 mutation status determined
Who cannot take part
- ✗Participants with a history of a malignant disease other than those being treated in this study
- ✗Participants with untreated, active, or causing symptoms central nervous system (CNS) metastases or carcinomatous meningitis
- ✗Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- ✗Participants with clinically significant lung disease or impaired lung function
- ✗Participants with clinically significant heart disease or impaired heart function
See the full criteria
Where Is This Study? (8 UK sites)
Queen Elizabeth Hospital Birmingham
Birmingham B15 2TH, United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
Cambridge CB20QQ, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L78YA, United Kingdom
Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
London W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester M204BX, United Kingdom
University of Oxford
Oxford Ox37LE, United Kingdom
Royal Marsden Hospital - Sutton
Surrey Quays SM2 5PT, United Kingdom
How to Get in Touch
Immunocore Medical Information
Sponsor contactCONTACT
Immunocore Medical Information EU
Sponsor contactCONTACT
