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A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2

Conditions

Melanoma

Treatments

Drug: nivolumab+rHuPH20
Drug: relatlimab+nivolumab+rHuPH20
Drug: relatlimab+nivolumab
Drug: nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06101134
U1111-1289-5947 (Other Identifier)
CA224-1044
2023-504515-33-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
  • Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Exclusion criteria

  • Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Cohort 1: Metastatic Melanoma
Experimental group
Treatment:
Drug: relatlimab+nivolumab
Drug: relatlimab+nivolumab+rHuPH20
Cohort 2: Resected Melanoma
Experimental group
Treatment:
Drug: nivolumab
Drug: nivolumab+rHuPH20

Trial contacts and locations

35

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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