Study of BMS-986158 in Subjects With Select Advanced Cancers

NCT02419417 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA011-0012015-000324-29
• Study Type: interventional
• Target: 83
• Locations: 5 countries
• Sites: 13

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Adverse Events

  Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

  From first dose to 30 days following last dose (up to approximately 29 months)

• Number of Participants With Abnormal Hepatic Test Values

  Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

  From first dose to 30 days following last dose (up to approximately 29 months)

Secondary Outcomes (26)

• Best Overall Response (BOR)

  From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

• Objective Response Rate (ORR)

  From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

• Duration of Response (DOR)

  From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)

• Progression Free Survival (PFS)

  From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)

• Progression Free Survival Rate (PFSR)

  From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose

Study Arms (2)

Monotherapy Treatment

EXPERIMENTAL

Patients treated at various doses and schedules

Drug: BMS-986158

Combination Therapy

EXPERIMENTAL

Patients treated at selected doses and schdules

Drug: BMS-986158; Biological: Nivolumab

Interventions

BMS-986158 DRUG

Specified dose on specified days

Combination Therapy; Monotherapy Treatment

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Combination Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have select advanced cancers with specific genetic profiles
• Must have received appropriate standard of care
• At least one measurable lesion at baseline
• Expected to have life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) of 0 to 1

You may not qualify if:

• Concomitant second malignancies
• Uncontrolled or significant cardiovascular disease
• Inadequate bone marrow function
• Chronic gastrointestinal illness
• Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (13)

City Of Hope National Medical Center

Duarte, California, 91010, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

Dana Farber Cancer Institute.

Boston, Massachusetts, 02215, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Univ. Of Pa

Philadelphia, Pennsylvania, 19104, United States

Location

Institute for Translational Oncology Research-ITOR

Greenville, South Carolina, 29605, United States

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Lyon, 69373, France

Location

Local Institution

Villejuif, 94800, France

Location

H. Univ. Vall dHebron

Barcelona, 08035, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 17, 2015
• Study Start: June 19, 2015
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: June 16, 2022
• Results First Posted: June 16, 2022

Record last verified: 2022-05

Locations

AU (1); US (6); FR (2); CA (1); ES (3)