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

Phase 1

Terminated

• Conditions: Cancer
• Interventions: Drug: BMS-986242; Biological: Nivolumab

• Registration Number: NCT03351231
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2017-11-27
• Primary Completion: 2018-08-28
• Study Completion: 2018-08-28
• Results First Submitted: 2019-08-22
• Results First Submitted QC: 2019-09-19
• Results First Posted: 2019-10-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
• Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Ability to swallow tablets
• Adequate bone marrow and organ function, as defined by the protocol

Read More

Exclusion Criteria

• Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
• Ocular melanoma
• Any significant acute or chronic medical illness
• Prior malignancy
• Other active malignancy requiring concurrent intervention
• Prior organ allograft or allogeneic bone marrow transplantation
• Participants with active, known, or suspected autoimmune disease
• Requirement for daily supplemental oxygen
• Uncontrolled or significant cardiovascular disease
• Pre-existing liver disease
• Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	BMS-986242	BMS-986242 administered in combination with Nivolumab
Dose Expansion	BMS-986242	BMS-986242 administered in combination with Nivolumab
Dose Escalation	Nivolumab	BMS-986242 administered in combination with Nivolumab
Dose Expansion	Nivolumab	BMS-986242 administered in combination with Nivolumab

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AE)	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
Number of Participants With Serious Adverse Events (SAE)	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
Number of Participants With Dose Limiting Toxicities (DLT)	Approximately 2 years	The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Number of Participants With AEs Leading to Discontinuation	Approximately 2 years	The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Number of Deaths	Approximately 2 years	The primary objective to establish safety to be measured by the primary endpoint of deaths
Number of Participants With Laboratory Abnormalities	Approximately 2 years	The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]	Approximately 2 years	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
Maximum Observed Plasma Concentration (Cmax)	Approximately 2 years	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
Time of Maximum Observed Plasma Concentration (Tmax)	Approximately 2 years	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
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]	Approximately 2 years	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
Apparent Total Body Clearance (CLT/F)	Approximately 2 years	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
Percent Urinary Recovery Over 24 Hours (%UR24)	Approximately 2 years	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
Apparent Elimination Half-life (T-HALF)	Approximately 2 years	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
Apparent Volume of Distribution at Steady State (Vss/F)	Approximately 2 years	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
Percent Urinary Recovery Over 72 Hours (%UR72)	Approximately 2 years	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
Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)	Approximately 2 years	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 (AI)	Approximately 2 years	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.
Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242	Approximately 2 years	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.
Overall Response Rate (ORR)	Approximately 2 years	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

Trial Locations

Locations (4)

Local Institution; 🇺🇸 Baltimore, Maryland, United States

University Of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Los Angeles, California, United States