A Phase I/2a study of BMS-986156 given alone and in combination with nivolumab in subjects with advanced solid tumors.

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002505-11-ES

Enrollment

300

Registered

2016-08-05

Start date

2016-09-19

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors MedDRA version: 19.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864

Interventions

Product Name: BMS-986156 Product Code: BMS-986156 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: BMS-986156 Other descriptive name: BMS98615

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For Dose Escalation: - Subjects with any previously treated advanced (metastatic or refractory) solid tumor For Cohort Expansion: - Subjects must have a previously treated advanced solid tumor to be eligible - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy - Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Known central nervous system metastases or central nervous system as the only source of disease - Other concomitant malignancies (with some exceptions per protocol) - Active, known or suspected autoimmune disease - Uncontrolled or significant cardiovascular disease - History of chronic hepatitis - History of active hepatitis (B or C) - Impaired liver or bone marrow function - Major surgery less than 1 month before start of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and MTD/MAD/alternate dose of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors.;Secondary Objective: - To investigate the preliminary anti-tumor activity of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors - To characterize the PK of BMS-986156 administered alone and in combination with nivolumab - To characterize the immunogenicity of BMS-986156 administered alone and in combination with nivolumab, and the immunogenicity of nivolumab administered with BMS-986156.;Primary end point(s): The assessment of safety will be based on the incidence of AEs, SAEs, adverse events leading to discontinuation, and deaths. In addition clinical laboratory test abnormalities will be examined;Timepoint(s) of evaluation of this end point: Non-serious AEs/SAEs will be collected starting with the first dose of study medication and through 100 days after discontinuation of dosing	—

Measure

Time frame

Main Objective: The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and MTD/MAD/alternate dose of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors.;Secondary Objective: - To investigate the preliminary anti-tumor activity of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors - To characterize the PK of BMS-986156 administered alone and in combination with nivolumab - To characterize the immunogenicity of BMS-986156 administered alone and in combination with nivolumab, and the immunogenicity of nivolumab administered with BMS-986156.;Primary end point(s): The assessment of safety will be based on the incidence of AEs, SAEs, adverse events leading to discontinuation, and deaths. In addition clinical laboratory test abnormalities will be examined;Timepoint(s) of evaluation of this end point: Non-serious AEs/SAEs will be collected starting with the first dose of study medication and through 100 days after discontinuation of dosing

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Secondary

Measure	Time frame
Secondary end point(s): 1/ ORR, duration of response, and progression free survival rate (PFSR) 2/ Selected BMS-986156 parameters, such as Cmax, Tmax, AUC-(TAU), AUC (0-T) will be assessed, if feasible, from concentration-time data 3/ Frequency of positivex ADA to BMS-986156 and or nivolumab;Timepoint(s) of evaluation of this end point: 1/ Every 8 weeks during treatment, response and survival follow-up periods 2/ During Cycle 1 and Cycle 3 3/ During Cycle 1, Cycle 2 and Cycle 3	—

Measure

Time frame

Secondary end point(s): 1/ ORR, duration of response, and progression free survival rate (PFSR) 2/ Selected BMS-986156 parameters, such as Cmax, Tmax, AUC-(TAU), AUC (0-T) will be assessed, if feasible, from concentration-time data 3/ Frequency of positivex ADA to BMS-986156 and or nivolumab;Timepoint(s) of evaluation of this end point: 1/ Every 8 weeks during treatment, response and survival follow-up periods 2/ During Cycle 1 and Cycle 3 3/ During Cycle 1, Cycle 2 and Cycle 3

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Countries

Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900 150 160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026