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Looking for participantsPhase3

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Sponsor: Immunocore Ltd

NCT ID: NCT06112314

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
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.

Advanced Melanoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

BRAF

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
Inclusion Criteria: * Participants must be HLA-A\*02:01-positive * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Participants must have measurable disease per RECIST 1.1 * Participant must have BRAF V600 mutation status determined * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention Exclusion Criteria: * Participants with a history of a malignant disease other than those being treated in this study * Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis * Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients * Participants with clinically significant pulmonary disease or impaired lung function * Participants with clinically significant cardiac disease or impaired cardiac function * Participants with active autoimmune disease requiring immunosuppressive treatment * Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results * Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma * Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Where Is This Study? (8 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre

Cambridge CB20QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool L78YA, United Kingdom

Recruiting
Site contact (verified)

Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)

London W1G 6AD, United Kingdom

COMPLETED

The Christie NHS Foundation Trust

Manchester M204BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

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

University of Oxford

Oxford Ox37LE, United Kingdom

Recruiting
Site contact (verified)
Dr Miranda Payne, MD01 865 74 1841

Royal Marsden Hospital - Sutton

Surrey Quays SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Immunocore Medical Information

Sponsor contact

CONTACT

844-466-8661 medical.information@immunocore.com

Immunocore Medical Information EU

Sponsor contact

CONTACT

+00 800-744-51111 medinfo.eu@immunocore.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02