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A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

  • Clinicaltrials.gov identifier

    NCT03400332

  • Recruitment Status

    Recruiting

  • First Posted

    January 17, 2018

  • Last update posted

    May 18, 2022

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

Study Description

Brief summary:

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

  • Condition or Disease:Cancer
    Melanoma
  • Intervention/Treatment: Drug: BMS-986253
    Biological: Nivolumab
    Biological: Ipilimumab
    Other: Placebo
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 372 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
  • Actual Study Start Date: February 2018
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: June 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: BMS-986253 + nivolumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 1B: BMS-986253 + nivolumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
 Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
    Part 1
  • 2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
    Part 1
  • 3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
    Part 1
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 1
  • 5. Incidence of deaths [ Time Frame: Approximately 5 years ]
    Part 1
  • 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 1
  • 7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 1
  • 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 1
  • 9. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1
  • Secondary Outcome Measures: 1. Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 2. Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 1
  • 3. Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 4. Serum biomarker concentration [ Time Frame: Approximately 5 years ]
    Part 1
  • 5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 6. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 9. Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 11. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
  • 12. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    Part 2
  • 13. Incidence of AEs [ Time Frame: Approximately 5 years ]
    Part 2
  • 14. Incidence of SAEs [ Time Frame: Approximately 5 years ]
    Part 2
  • 15. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 2
  • 16. Incidence of death [ Time Frame: Approximately 5 years ]
    Part 2
  • 17. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 2
  • 18. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 2
  • 19. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 2

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 a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 At least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) Participants with active, known or suspected autoimmune disease Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy 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, Arkansas
Local Institution
Springdale

United States, Colorado
Local Institution
Aurora

United States, Colorado
Rocky Mountain Cancer Centers
Denver

United States, Florida
Local Institution
Miami Beach

United States, Georgia
Local Institution
Atlanta

United States, Maryland
Maryland Oncology Hematology P.A.
Columbia

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

United States, Michigan
University Of Michigan Health System
Ann Arbor

United States, Nebraska
Local Institution
Omaha

United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas

United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

United States, New York
Icahn School Of Medicine At Mount Sinai
New York

United States, New York
Columbia University Medical Center (Cumc)
New York

United States, Oklahoma
Stephenson Cancer Center
Oklahoma City

United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene

United States, Pennsylvania
Local Institution
Philadelphia

United States, Pennsylvania
UPMC Cancer Center
Pittsburgh

United States, South Carolina
Greenville Health System
Greenville

United States, Texas
Texas Oncology-Austin Midtown
Austin

United States, Texas
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas

United States, Texas
Local Institution
Fort Worth

United States, Texas
MD Anderson Cancer Center
Houston

United States, Texas
Texas Oncology-San Antonio Medical Center
San Antonio

United States, Texas
Texas Oncology - DFWW
Tyler

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Virginia Cancer Specialists, PC
Fairfax

United States, Virginia
Virginia Oncology Associates
Norfolk

United States, Virginia
Local Institution
Richmond

Australia, New South Wales
Local Institution
Wollstonecraft

Australia, South Australia
Local Institution
Adelaide

Australia, Victoria
Local Institution
Ballarat Central

Australia, Victoria
Local Institution
Epping

Australia, Victoria
Local Institution - 0095
Melbourne

Australia, Western Australia
Local Institution
Nedlands

Belgium
Local Institution
Bruxelles

Belgium
Local Institution - 0036
Gent

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution - 0029
Vancouver

Canada, British Columbia
Local Institution
Victoria

Canada, Ontario
Local Institution
Toronto

Canada, Ontario
Local Institution
Toronto

Canada
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies
Montréal

France
Local Institution - 0067
Marseille

France
Local Institution - 0085
Nantes

France
Local Institution - 0068
Paris

France
Local Institution
Villejuif

Germany
Local Institution
Berlin

Germany
Local Institution
Gerlingen

Germany
Local Institution
Hamburg

Germany
Local Institution
Hamburg

Germany
Local Institution
Mainz

Germany
Local Institution
Mainz

Germany
Local Institution
Tuebingen

Italy
IRST Meldola
Forlì

Italy
Local Institution - 0042
Milano

Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli

Italy
Local Institution
Rozzano-milano

Poland
Local Institution
Krakow

Poland
Local Institution
Warszawa

Spain
Local Institution - 0045
Madrid

Spain
Local Institution - 0022
Madrid

Spain
Local Institution - 0023
Madrid

Spain
Hospital Universitario Virgen De La Victoria
Malaga

Spain
Local Institution - 0021
Pamplona

Spain
Hospital Clinico Univ. de Santiago-CHUS
Santiago Compostela

Switzerland
Chu Vaudois Lausanne
Lausanne

Switzerland
Kantonsspital St. Gallen
St.Gallen

Switzerland
University Hospital Zuerich
Zuerich

United Kingdom, Greater Manchester
Local Institution - 0024
Manchester

United Kingdom, West Midlands
Local Institution
Birmingham

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: NCT03400332 History of Changes
  • Other Study ID Numbers: CA027-002, 2018-000340-26
  • First Posted: January 17, 2018 Key Record Dates
  • Last Update Posted: May 18, 2022
  • Last Verified: May 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Melanoma
    Neuroendocrine Tumors
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal     Neoplasms by Histologic Type
    Neoplasms
    Neoplasms, Nerve Tissue
    Nevi and Melanomas