All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

BMS-986242 administered in combination with Nivolumab

BMS-986242

Bristol-Myers Squibb

The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.

An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors

The primary objective to establish safety to be measured by the primary endpoint of AEs

The primary objective to establish safety to be measured by the primary endpoint of SAEs

The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities

The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation

The primary objective to establish safety to be measured by the primary endpoint of deaths

The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities

The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0.

Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.

Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.

ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors

The study will not be reported due to privacy reasons

2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments

BMS-986242 12.5 mg + Nivolumab 480 mg

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All treated participants; Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.

Bristol-Myers Squibb Study Director

Study terminated, data not reported due to privacy reasons

Spots Global Cancer Trial Database for An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial