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

Cancer Clinical Trial

Official title:

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03400332
• Other study ID #: CA027-002
• Secondary ID: 2018-000340-26
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 12, 2018
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 372
• Est. completion date: November 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Melanoma

Intervention

Drug:
• BMS-986253
Specified dose on specified days

Biological:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0096	Adelaide	South Australia
Australia	Local Institution - 0091	Ballarat Central
Australia	Local Institution - 0090	Melbourne	Victoria
Australia	Local Institution - 0095	Melbourne	Victoria
Australia	Local Institution - 0097	Perth	Western Australia
Australia	Local Institution - 0088	Wollstonecraft	New South Wales
Belgium	Local Institution - 0037	Bruxelles
Belgium	Local Institution - 0036	Gent
Belgium	Local Institution - 0082	Kortrijk
Canada	Local Institution - 0030	Edmonton	Alberta
Canada	Local Institution - 0056	Montréal
Canada	Local Institution - 0020	Toronto	Ontario
Canada	Local Institution - 0055	Toronto	Ontario
Canada	Local Institution - 0029	Vancouver	British Columbia
Canada	Local Institution - 0078	Victoria	British Columbia
France	Local Institution - 0067	Marseille	Bouches-du-Rhône
France	Local Institution - 0085	Nantes
France	Local Institution - 0068	Paris
France	Local Institution - 0102	Toulouse
France	Local Institution - 0069	Villejuif
Germany	Local Institution - 0034	Berlin
Germany	Local Institution - 0053	Hamburg
Germany	Local Institution - 0052	Mainz	Rheinland-Pfalz
Germany	Local Institution - 0054	Tübingen	Baden-Württemberg
Italy	Local Institution - 0043	Forlì
Italy	Local Institution - 0042	Milano
Italy	Local Institution - 0027	Napoli
Italy	Local Institution - 0026	Rozzano-milano
Poland	Local Institution - 0071	Krakow
Poland	Local Institution - 0077	Warszawa
Spain	Local Institution - 0022	Madrid
Spain	Local Institution - 0023	Madrid
Spain	Local Institution - 0045	Madrid
Spain	Local Institution - 0044	Malaga
Spain	Local Institution - 0021	Pamplona
Spain	Local Institution - 0047	Santiago de Compostela
Sweden	Local Institution - 0049	Lund
Switzerland	Local Institution - 0040	Lausanne
Switzerland	Local Institution - 0041	St.Gallen
Switzerland	Local Institution - 0039	Zuerich
United Kingdom	Local Institution - 0019	Birmingham	West Midlands
United Kingdom	Local Institution - 0083	Glasgow	Lanarkshire
United Kingdom	Local Institution - 0024	Manchester	Greater Manchester
United States	University Of Michigan Health System	Ann Arbor	Michigan
United States	Local Institution - 0087	Atlanta	Georgia
United States	Local Institution - 0100	Atlanta	Georgia
United States	Local Institution - 0011	Austin	Texas
United States	Local Institution - 0060	Boston	Massachusetts
United States	Local Institution - 0012	Columbia	Maryland
United States	Local Institution - 0010	Dallas	Texas
United States	Local Institution - 0017	Eugene	Oregon
United States	Local Institution - 0015	Fairfax	Virginia
United States	Texas Oncology-Fort Worth 12th Ave	Fort Worth	Texas
United States	Local Institution - 0009	Greenville	South Carolina
United States	Local Institution - 0005	Hackensack	New Jersey
United States	Local Institution - 0018	Houston	Texas
United States	Local Institution - 0007	Lakewood	Colorado
United States	Comprehensive Cancer Centers Of Nevada	Las Vegas	Nevada
United States	Local Institution - 0099	Los Angeles	California
United States	Local Institution - 0003	Lutherville	Maryland
United States	Local Institution - 0101	Marietta	Georgia
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Local Institution - 0002	New York	New York
United States	Local Institution - 0025	New York	New York
United States	Local Institution - 0008	Norfolk	Virginia
United States	Local Institution - 0028	Oklahoma City	Oklahoma
United States	Local Institution - 0076	Omaha	Nebraska
United States	Local Institution - 0001	Pittsburgh	Pennsylvania
United States	Local Institution - 0058	Salt Lake City	Utah
United States	Local Institution - 0006	San Antonio	Texas
United States	Local Institution - 0059	Springdale	Arkansas
United States	Local Institution - 0013	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting