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

  • Clinicaltrials.gov identifier

    NCT03459222

  • Recruitment Status

    Recruiting

  • First Posted

    March 8, 2018

  • Last update posted

    October 22, 2020

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

Study Description

Brief summary:

The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Biological: Relatlimab
    Biological: Nivolumab
    Drug: BMS-986205
    Biological: Ipilimumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 230 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
  • Actual Study Start Date: May 2018
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205		 Biological: Relatlimab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Drug: BMS-986205
Specified dose on specified days
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab		 Biological: Relatlimab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
  • 2. Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
  • 3. Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]
  • 4. Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
  • 5. Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
  • 6. Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
  • 7. Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  • 8. Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
  • Secondary Outcome Measures: 1. Progression Free Survival (PFS) [ Time Frame: up to 4 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic or cytologic confirmation of an incurable solid malignancy that is 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: - Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease - Participants with a history of interstitial lung disease (ILD) / pneumonitis - Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
City of Hope National Medical Center
Duarte

United States, Colorado
University Of Colorado
Aurora

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore

United States, Missouri
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis

United States, Tennessee
The West Clinic, P.C.
Germantown

United States, Washington
Local Institution
Seattle

Australia, New South Wales
Melanoma Institute Australia
North Sydney

Australia, Western Australia
Linear Clinical Research Ltd
Nedlands

France
Hopital De La Timone
Marseille Cedex 5

France
Institut Claudius Regaud
Toulouse

France
Institut Gustave Roussy
Villejuif

Italy
IRST Meldola
Forli

Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli

Spain
Hospital Clinic I Provincial
Barcelona

Spain
Centro Integral Oncologico Clara Campal
Madrid

Spain
Clinica Universidad de Navarra
Pamplona

Switzerland
Chu Vaudois Lausanne
Lausanne

Switzerland
Universitaetsspital Zuerich
Zuerich

United Kingdom
Local Institution
Newcastle Upon Tyne

United Kingdom
Local Institution
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03459222 History of Changes
  • Other Study ID Numbers: CA224-048, 2018-000058-22
  • First Posted: March 8, 2018 Key Record Dates
  • Last Update Posted: October 22, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Relatlimab immunotherapy