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

NCT ID: NCT06101134

Last Updated: 2025-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: Metastatic Melanoma

Group Type EXPERIMENTAL

relatlimab+nivolumab

Intervention Type DRUG

Specified dose on specified days

relatlimab+nivolumab+rHuPH20

Intervention Type DRUG

Specified dose on specified days

Cohort 2: Resected Melanoma

Group Type EXPERIMENTAL

nivolumab

Intervention Type DRUG

Specified dose on specified days

nivolumab+rHuPH20

Intervention Type DRUG

Specified dose on specified days

Interventions

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relatlimab+nivolumab

Specified dose on specified days

Intervention Type DRUG

relatlimab+nivolumab+rHuPH20

Specified dose on specified days

Intervention Type DRUG

nivolumab

Specified dose on specified days

Intervention Type DRUG

nivolumab+rHuPH20

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986213 Opdualag BMS-936558 Opdivo BMS-986298

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0007

Anchorage, Alaska, United States

Site Status

Local Institution - 0013

Phoenix, Arizona, United States

Site Status

Local Institution - 0010

San Francisco, California, United States

Site Status

Local Institution - 0034

Atlanta, Georgia, United States

Site Status

Local Institution - 0032

Edgewood, Kentucky, United States

Site Status

Local Institution - 0028

Albuquerque, New Mexico, United States

Site Status

Local Institution - 0037

Edmonds, Washington, United States

Site Status

Local Institution - 0036

Issaquah, Washington, United States

Site Status

Local Institution - 0030

Seattle, Washington, United States

Site Status

Local Institution - 0015

Las Condes, Santiago Metropolitan, Chile

Site Status

Local Institution - 0005

Concepción, , Chile

Site Status

Local Institution - 0019

Thessaloniki, B, Greece

Site Status

Local Institution - 0014

Athens, I, Greece

Site Status

Local Institution - 0029

Marousi, I, Greece

Site Status

Local Institution - 0023

Holargos, Athens, , Greece

Site Status

Local Institution - 0008

Piraeus, , Greece

Site Status

Local Institution - 0033

Thessaloniki, , Greece

Site Status

Local Institution - 0017

Bergamo, BG, Italy

Site Status

Local Institution - 0035

Meldola, FC, Italy

Site Status

Local Institution - 0018

Milan, MI, Italy

Site Status

Local Institution - 0012

Padua, PD, Italy

Site Status

Local Institution - 0021

Roma, RM, Italy

Site Status

Local Institution - 0004

Torino, TO, Italy

Site Status

Local Institution - 0026

Napoli, , Italy

Site Status

Local Institution - 0011

Barcelona, B, Spain

Site Status

Local Institution - 0022

Barcelona, B, Spain

Site Status

Local Institution - 0009

Cartagena, MU, Spain

Site Status

Local Institution - 0020

Badalona, , Spain

Site Status

Local Institution - 0027

Cantabria, , Spain

Site Status

Local Institution - 0003

San Pedro Alcántara, Málaga, , Spain

Site Status

Local Institution - 0006

Seville, , Spain

Site Status

Countries

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United States Chile Greece Italy Spain

Related Links

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Other Identifiers

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U1111-1289-5947

Identifier Type: OTHER

Identifier Source: secondary_id

2023-504515-33-00

Identifier Type: OTHER

Identifier Source: secondary_id

CA224-1044

Identifier Type: -

Identifier Source: org_study_id

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