NCT03400332 - Bristol Myers Squibb™

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
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 Phase 1/2 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
Primary Outcome Measures: 2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 5. Incidence of deaths [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
Part 1
Primary Outcome Measures: 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
Secondary Outcome Measures: 2. Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
Part 1
Secondary Outcome Measures: 3. Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 4. Serum biomarker concentration [ Time Frame: Approximately 5 years ]
Part 1
Secondary Outcome Measures: 5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 6. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 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
Secondary Outcome Measures: 8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 9. Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]
Part 1 and Part 2
Secondary Outcome Measures: 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)
Secondary Outcome Measures: 12. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 13. Incidence of AEs [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 14. Incidence of SAEs [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 15. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 16. Incidence of death [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 17. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 18. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
Part 2
Secondary Outcome Measures: 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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
Rocky Mountain Cancer Centers
Denver

United States, Florida
Local Institution
Miami Beach

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, 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, P.A.
Tyler

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Virginia Cancer Specialists, PC
Fairfax

United States, Virginia
Virginia Oncology Associates
Norfolk

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Gent

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montréal

Germany
Local Institution
Berlin

Germany
Local Institution
Gerlingen

Germany
Local Institution
Hamburg

Germany
Local Institution
Mainz

Germany
Local Institution
Tübingen

Italy
Local Institution
Forlì

Italy
Local Institution
Milano

Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli

Italy
Local Institution
Rozzano-milano

Spain
Hospital Universitario Ramon Y Cajal
Madrid

Spain
Fundacion Jimenez Diaz
Madrid

Spain
Centro Integral Oncologico Clara Campal
Madrid

Spain
Hospital Universitario Virgen De La Victoria
Malaga

Spain
Clinica Universidad de Navarra
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
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 11, 2021
Last Verified: May 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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Clinical Trials of Interest

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

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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Condition Categories

Clinical Trials of Interest

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

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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