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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06112314
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Immunocore Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Melanoma

Arms & Interventions

Arms

Experimental: Arm A: Brenetafusp Low Dose + Nivolumab

Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.

Experimental: Arm B: Brenetafusp High Dose + Nivolumab

Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.

Active Comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab

Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.

Interventions

Drug: - 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.

Drug: - Nivolumab

Concentrate for solution for infusion at a unit dose of 10 mg/mL.

Drug: - Nivolumab + Relatlimab

Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California - San Diego, La Jolla, California

Status

Recruiting

Address

University of California - San Diego

La Jolla, California, 92093-0698

Site Contact

Katie O'Neil

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