Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

Official 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

Keywords

Advanced Melanoma, Melanoma, Nivolumab, Relatlimab, IMC-F106C, Nivolumab + Relatlimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94143 United States
  • UCLA Department of Medicine- Hematology/Oncology
    Westwood California 90024 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Immunocore Ltd
ID
NCT06112314
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 680 study participants
Last Updated