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

NCT03459222 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA224-0482018-000058-22
• Study Type: interventional
• Target: 229
• Locations: 7 countries
• Sites: 22

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Immunotherapy; Relatlimab; Nivolumab; Ipilimumab; BMS-986205

Outcome Measures

Primary Outcomes (9)

• Number of clinical laboratory test abnormalities

  Approximately 4 years

• Number of Adverse Events (AEs)

  Approximately 4 years

• Number of Serious Adverse Events (SAEs)

  Approximately 4 years

• Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

  Up to 6 weeks

• Number of AEs leading to discontinuation

  Approximately 4 years

• Number of AEs leading to death

  Approximately 4 years

• Objective Response Rate (ORR)

  Approximately 4 years

• Disease Control Rate (DCR)

  Approximately 4 years

• Median Duration of Response (mDOR)

  Approximately 4 years

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  Up to 4 years

Study Arms (2)

Arm A

EXPERIMENTAL

Relatlimab + Nivolumab + BMS-986205

Biological: Relatlimab; Biological: Nivolumab; Drug: BMS-986205

Arm B

EXPERIMENTAL

Relatlimab + Nivolumab + Ipilimumab

Biological: Relatlimab; Biological: Nivolumab; Biological: Ipilimumab

Interventions

Relatlimab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986016

Arm A; Arm B

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm A; Arm B

BMS-986205 DRUG

Specified dose on specified days

Also known as: Linrodostat

Arm A

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: Yervoy, BMS-734016

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (22)

Local Institution - 0006

Duarte, California, 91010, United States

Location

Local Institution - 0003

Aurora, Colorado, 80045, United States

Location

Local Institution - 0004

Baltimore, Maryland, 21231, United States

Location

Local Institution - 0005

St Louis, Missouri, 63110, United States

Location

Local Institution - 0001

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0012

Wollstonecraft, New South Wales, 2065, Australia

Location

Local Institution - 0011

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0017

Marseille, 13385, France

Location

Local Institution - 0016

Toulouse, 31059, France

Location

Local Institution - 0015

Villejuif, 94800, France

Location

Local Institution - 0010

Forlì, 47014, Italy

Location

Local Institution - 0009

Napoli, 80131, Italy

Location

Local Institution - 0023

Rome, 00144, Italy

Location

Local Institution - 0019

Barcelona, 08036, Spain

Location

Local Institution - 0021

Madrid, 28041, Spain

Location

Local Institution - 0018

Madrid, 28050, Spain

Location

Local Institution - 0022

Málaga, 29011, Spain

Location

Local Institution - 0020

Pamplona, 31008, Spain

Location

Local Institution - 0008

Lausanne, 1011, Switzerland

Location

Local Institution - 0007

Zurich, 8091, Switzerland

Location

Local Institution - 0013

Headington, OX3 7LE, United Kingdom

Location

Local Institution - 0014

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

relatlimab; Nivolumab; linrodostat; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: May 30, 2018
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

AU (2); IT (3); ES (5); CH (2); GB (2); FR (3); US (5)