A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is l

Trial Details

NCT ID
NCT06246916
Phase
PHASE3
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • fianlimab
  • cemiplimab
  • relatlimab+nivolumab
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Fullerton, California, United States|33.87029,-117.92534

Key Eligibility Criteria

  • Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC),…
  • Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
  • Measurable disease per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Melanoma Trials on Trialify →