Comparing 3 approaches for advanced melanoma
Official title: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301
Interventions
Brenetafusp
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
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Nivolumab + Relatlimab
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
Canadian Sites (2)
Cross Cancer Institute
Edmonton, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must have BRAF V600 mutation status determined
- +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
- +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 controlControl groupThe group a new treatment is measured against.Read more → from the study screeningScreeningThe checks done before joining, to see whether a study fits.Read more → date until 5 months after the final dose of study intervention
Exclusion
- −Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- −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
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s or SponsorSponsorThe organisation responsible for the study overall.Read more →'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 AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → related to prior anti-PD-(L)1 or anti-LAG-3
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Brenetafusp, Nivolumab, Nivolumab + Relatlimab.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 680 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: Up to ~45 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) — measured over Up to ~45 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06112314 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BrenetafuspDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About NivolumabDrug
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Nivolumab + RelatlimabDrug
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to ~45 months.
The study as a whole is currently expected to finish around 2027-10-16.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 680 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Edmonton, Canada; Toronto, Ontario, Canada; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Lake Success, New York, United States; New York, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (5)
Henry Ford Cancer Center - Michigan
Detroit, Michigan, United States
Allina Health Cancer Institute - Minneapolis
Minneapolis, Minnesota, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
Columbia University Medical Center
New York, New York, United States
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.