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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03351231
• Other study ID #: CA024-001
• Secondary ID: 2017-003603-21
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 27, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• BMS-986242
Specified dose on specified days

Biological:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution	Baltimore	Maryland
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Hoag Memorial Hospital Presbyterian	Los Angeles	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AE)	The primary objective to establish safety to be measured by the primary endpoint of AEs	From initiation of study treatment until 100 days after discontinuation of study treatment
Primary	Number of Participants With Serious Adverse Events (SAE)	The primary objective to establish safety to be measured by the primary endpoint of SAEs	From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
Primary	Number of Participants With Dose Limiting Toxicities (DLT)	The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities	Approximately 2 years
Primary	Number of Participants With AEs Leading to Discontinuation	The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation	Approximately 2 years
Primary	Number of Deaths	The primary objective to establish safety to be measured by the primary endpoint of deaths	Approximately 2 years
Primary	Number of Participants With Laboratory Abnormalities	The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities	Approximately 2 years
Secondary	Maximum Observed Plasma Concentration (Cmax)	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	Approximately 2 years
Secondary	Time of Maximum Observed Plasma Concentration (Tmax)	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	Approximately 2 years
Secondary	Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]	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	Approximately 2 years
Secondary	Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]	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	Approximately 2 years
Secondary	Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)	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	Approximately 2 years
Secondary	Apparent Elimination Half-life (T-HALF)	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	Approximately 2 years
Secondary	Apparent Total Body Clearance (CLT/F)	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	Approximately 2 years
Secondary	Apparent Volume of Distribution at Steady State (Vss/F)	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	Approximately 2 years
Secondary	Accumulation Index (AI)	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.	Approximately 2 years
Secondary	Percent Urinary Recovery Over 24 Hours (%UR24)	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	Approximately 2 years
Secondary	Percent Urinary Recovery Over 72 Hours (%UR72)	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	Approximately 2 years
Secondary	Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242	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.	Approximately 2 years
Secondary	Overall Response Rate (ORR)	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	Approximately 2 years

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