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NCT Number: NCT06112314

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clínica Adventista Belgrano - Sector Investigación, Caba, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IMC-F106C

Nivolumab

Drug

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

Other names: OPDIVO

Nivolumab + Relatlimab

Drug

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

Other names: OPDUALAG

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to ~45 months

    PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to ~57 months

    OS is the time from randomization to time of death from any cause.

  2. Overall Response Rate (ORR)

    Time frame: Up to ~45 months

    ORR as assessed by BICR according to RECIST 1.1.

  3. Number of Participants Experiencing ≥1 Adverse Event (AE)

    Time frame: Up to ~57 months

    An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur in the study.

  4. Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)

    Time frame: Up to ~57 months

    An SAE is any untoward medical consequence that results in death; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or any other important medical event in the opinion of the Investigator.

  5. Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation

    Time frame: Up to ~45 months

    The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.

  6. Maximum Plasma Concentration (Cmax) of IMC-F106C

    Time frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose

    The Cmax of IMC-F106C will be reported.

  7. Incidence of anti-IMC-F106C Antibodies

    Time frame: Up to ~45 months

    The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.

  8. Association between PFS and Intra-Tumor Immune Cells

    Time frame: Up to ~45 months

    The potential association between the effect of IMC-F106C on efficacy and intra-tumor environment will be explored. Intra-tumor environment is estimated as the ratio of CD3+ to CD163+ cells and the correlation with PFS will be estimated by the hazard ratio (+/- 95% CI) from a Cox model. This analysis will be restricted to subjects randomized to receive IMC-F106C.

  9. Health-Related Quality of Life

    Time frame: Up to ~45 months

    The change from baseline over time and between treatments of health-related quality of life will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Immunocore Medical Information

CONTACT

[email protected]

844-466-8661

Immunocore Medical Information EU

CONTACT

[email protected]

+00 800-744-51111

Sponsors and collaborators

Lead sponsor

Immunocore Ltd

Industry

Registry information

Official study title

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

Acronym: PRISM-MEL-301

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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