An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

NCT ID: NCT03459222

Last Updated: 2025-04-02

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2025-02-19

Brief Summary

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The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

Detailed Description

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Conditions

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Advanced Cancer

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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Arm A

Relatlimab + Nivolumab + BMS-986205

Group Type EXPERIMENTAL

Relatlimab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

BMS-986205

Intervention Type DRUG

Specified dose on specified days

Arm B

Relatlimab + Nivolumab + Ipilimumab

Group Type EXPERIMENTAL

Relatlimab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Relatlimab

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

BMS-986205

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-986016 Opdivo BMS-936558 Linrodostat Yervoy BMS-734016

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
* Available tumor tissue for biomarker analysis
* Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

Exclusion Criteria

* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
* History of interstitial lung disease / pneumonitis
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
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 - 0006

Duarte, California, United States

Site Status

Local Institution - 0003

Aurora, Colorado, United States

Site Status

Local Institution - 0004

Baltimore, Maryland, United States

Site Status

Local Institution - 0005

St Louis, Missouri, United States

Site Status

Local Institution - 0001

Germantown, Tennessee, United States

Site Status

Local Institution - 0012

Wollstonecraft, New South Wales, Australia

Site Status

Local Institution - 0011

Nedlands, Western Australia, Australia

Site Status

Local Institution - 0017

Marseille, , France

Site Status

Local Institution - 0016

Toulouse, , France

Site Status

Local Institution - 0015

Villejuif, , France

Site Status

Local Institution - 0010

Forlì, , Italy

Site Status

Local Institution - 0009

Napoli, , Italy

Site Status

Local Institution - 0023

Rome, , Italy

Site Status

Local Institution - 0019

Barcelona, , Spain

Site Status

Local Institution - 0021

Madrid, , Spain

Site Status

Local Institution - 0018

Madrid, , Spain

Site Status

Local Institution - 0022

Málaga, , Spain

Site Status

Local Institution - 0020

Pamplona, , Spain

Site Status

Local Institution - 0008

Lausanne, , Switzerland

Site Status

Local Institution - 0007

Zurich, , Switzerland

Site Status

Local Institution - 0013

Headington, , United Kingdom

Site Status

Local Institution - 0014

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Australia France Italy Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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2018-000058-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA224-048

Identifier Type: -

Identifier Source: org_study_id

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