Study of BMS-986158 in Subjects With Select Advanced Cancers (BET)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Tumors

Treatments: Biological: Nivolumab; Drug: BMS-986158

Study type: Interventional

Funder types: Industry

Identifiers

NCT02419417

CA011-001

2015-000324-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 83 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Monotherapy Treatment

Experimental group

Description:

Patients treated at various doses and schedules

Treatment:

Drug: BMS-986158

Combination Therapy

Experimental group

Description:

Patients treated at selected doses and schdules

Treatment:

Biological: Nivolumab

Drug: BMS-986158