NCT03351231

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

Terminated Phase 1, PHASE2 Results posted Last updated 26 August 2020

What this trial tests

Phase 1, PHASE2 trial testing BMS-986242 in Cancer in 7 participants. Terminated before completion.

Timeline

27 November 2017

Primary endpoint
28 August 2018

28 August 2018

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	27 November 2017
Primary completion	28 August 2018
Estimated completion	28 August 2018
Sites	4 locations across United States

Drugs / interventions tested

• BMS-986242 — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AE) Primary · From initiation of study treatment until 100 days after discontinuation of study treatment

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Number of Participants With Serious Adverse Events (SAE) Primary · From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Number of Participants With Dose Limiting Toxicities (DLT) Primary · Approximately 2 years

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Number of Participants With AEs Leading to Discontinuation Primary · Approximately 2 years

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Number of Deaths Primary · Approximately 2 years

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Number of Participants With Laboratory Abnormalities Primary · Approximately 2 years

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

Group	Value	95% CI
BMS-986242 12.5 mg + Nivolumab 480 mg	NA

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.