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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (BMS CA224-098 RELATIVITY)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05002569

Background Information

The purpose of this study is to see if treating stage III-IV resectable melanoma patients with relatlimab and nivolumab after they have surgery to remove all tumors will reduce the probability of having progressive disease when compared to nivolumab alone. This study will also as assess the possible side effects that this combination therapy might have.

Nivolumab is approved to treat melanoma. Relatlimab is not approved by the Food and Drug Administration (FDA) in the United States or by health authorities in other countries. The combination of relatlimab and nivolomab is considered investigational.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Participants must have been diagnosed with, and cytologically or histologically confirmed, stage IIIA with >1 mm tumor in lymph node, IIIB, IIIC, IIID or IV completely resected cutaneous melanoma (AJCC Cancer Staging, 8th edition). All melanomas, except ocular/uveal and mucosal melanoma, regardless of primary site of disease will be allowed
  • Participants are eligible if central nervous system (CNS) metastases have been resected and participants are neurologically stable
  • Age 18 years or older
  • Additional eligibility in protocol

Ineligibility Information

  • History of uveal melanoma
  • Pregnancy/breastfeeding
  • Untreated/unresected CNS metastases or leptomeningeal metastases
  • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways)
  • Prior treatment with LAG-3 targeted agents
  • Any positive test result for hepatitis B virus (HBV) indicating presence of virus (eg, Hepatitis B surface antigen [HBsAg, Australia antigen]) positive
  • Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid [RNA]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll
  • Known human immunodeficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count < 350 cells/uL. Participants with HIV are eligible if:
    • They have received antiretroviral therapy (ART) for at least 4 weeks prior to randomizations as clinically indicated while enrolled on study
    • They continue on ART as clinically indicated while enrolled on study
    • CD4 counts and viral load are monitored per standard of care by a local health care provider
  • Additional ineligibility in protocol.