"A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma"

NOT ENROLLING
Protocol # :
18-096
Conditions
Melanoma
Phase
II/III
Disease Sites
Melanoma, Skin
Principal Investigator
Hodi, Frank, Stephen
Site Investigator
McDermott, David, F.
Site Research Nurses
D'Alessandro, Christine, M.
Gormley, Jill, Kathleen
Livengood, Amanda
Marujo, Rose

Trial Description

The purpose of this study is to determine whether relatlimab in combination with nivolumab is
more effective than nivolumab by itself in treating unresectable melanoma or melanoma that
has spread.

Eligibility Requirements

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
melanoma, per the AJCC staging system

- Participants must not have had prior systemic anticancer therapy for unresectable or
metastatic melanoma

- Tumor tissue from an unresectable or metastatic site of disease must be provided for
biomarker analyses

Exclusion Criteria:

- Participants must not have active brain metastases or leptomeningeal metastases

- Participants must not have uveal melanoma

- Participants must not have an active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

18-096