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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

    September 15, 2022

Study Description

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.

  • 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: 255 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
  • Actual Study Start Date: May 2018
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: July 2024

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. Number of AEs leading to death [ Time Frame: Approximately 4 years ]
  • 2. Objective Response Rate (ORR) [ Time Frame: Approximately 4 years ]
  • 3. Disease Control Rate (DCR) [ Time Frame: Approximately 4 years ]
  • 4. Median Duration of Response (mDOR) [ Time Frame: Approximately 4 years ]
  • 5. Number of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
  • 6. Number of clinical laboratory test abnormalities [ Time Frame: Approximately 4 years ]
  • 7. Number of Adverse Events (AEs) [ Time Frame: Approximately 4 years ]
  • 8. Number of Serious Adverse Events (SAEs) [ Time Frame: Approximately 4 years ]
  • 9. Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  • 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

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 Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations

United States, California
Local Institution - 0006
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, Ohio
Local Institution
Cleveland

United States, Tennessee
Local Institution - 0001
Germantown

United States, Washington
Local Institution
Seattle

Australia, New South Wales
Local Institution - 0012
Wollstonecraft

Australia, Western Australia
Local Institution - 0011
Nedlands

France
Local Institution - 0017
Marseille Cedex 5

France
Local Institution - 0016
Toulouse Cedex 9

France
Local Institution - 0015
Villejuif

Italy
Local Institution - 0010
Forlì

Italy
Local Institution - 0009
Napoli

Italy
Local Institution
Roma

Spain
Hospital Clinic I Provincial
Barcelona

Spain
Local Institution - 0021
Madrid

Spain
Local Institution - 0018
Madrid

Spain
Local Institution - 0022
Málaga

Spain
Local Institution - 0020
Pamplona

Switzerland
Local Institution - 0008
Lausanne

Switzerland
Local Institution - 0007
Zuerich

United Kingdom
Local Institution - 0013
Headington

United Kingdom
Local Institution - 0014
Newcastle Upon Tyne

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: September 15, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Immunotherapy
    Relatlimab
    Nivolumab
    Ipilimumab
    BMS-986205