No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
680 (estimated)
Sponsor
Immunocore Ltd · Industry
Who this trial is looking for
This trial is looking for people with advanced melanoma who have not been treated before. Participants will take the treatment IMC-F106C along with nivolumab to see how it works compared to standard nivolumab treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am HLA-A*02:01-positive
I have been diagnosed with Stage IV or unresectable Stage III melanoma
I have a tumor tissue sample that is confirmed as adequate
I have measurable disease according to RECIST 1.1
I know my BRAF V600 mutation status
My Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1
I agree to use effective birth control if I am sexually active and can have children
You may not be able to join if
I have a history of another type of cancer
I have untreated or active brain tumors or meningitis
I am allergic to IMC-F106C, nivolumab, or related drugs
I have significant lung disease
I have significant heart disease
I have active autoimmune disease needing treatment
I have a medical condition that might affect my safety or study participation
I have received prior systemic cancer treatment for melanoma
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility 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
* Part…
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
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