Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Warren Chow (uci)

Description

Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Official Title

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Keywords

Melanoma, Nivolumab, Relatlimab, FDC, rHuPH20, OPDUALAG, Nivolumab + Relatlimab, Nivolumab + Relatlimab FDC SC, Nivolumab + Relatlimab FDC IV

Eligibility

You can join if…

Open to people ages 12 years and up

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

You CAN'T join if...

  • Participants must not have ocular melanoma.
  • Participants must not have a history of myocarditis, regardless of etiology.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • Local Institution - 0098
    Los Angeles California 90025 United States
  • Local Institution - 0093
    Orange California 92868-3201 United States
  • Local Institution - 0123
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Warren Chow (uci)
    Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 47 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
ID
NCT05625399
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
About 579 people participating
Last Updated