Clinical Trials/NCT02966548

NCT02966548

Completed

Phase 1

A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Bristol-Myers Squibb1 site in 1 country35 target enrollmentJanuary 4, 2017

ConditionsCancer

InterventionsRelatlimab Nivolumab

DrugsRelatlimab Nivolumab

Overview

Phase: Phase 1
Intervention: Relatlimab
Conditions: Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 35
Locations: 1
Primary Endpoint: Number of laboratory abnormalities
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

January 4, 2017

End Date

July 9, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
•Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
•Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
•Males and Females, ages 20 years or older, inclusive

Exclusion Criteria

•Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
•Other concomitant malignancies (with some exceptions per protocol)
•Any active autoimmune disease or history of known or suspected autoimmune disease
•History of uncontrolled or significant cardiovascular disease
•Other protocol defined inclusion/exclusion criteria could apply

Arms & Interventions

Monotherapy

Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation

Intervention: Relatlimab

Combination Therapy

Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation

Intervention: Relatlimab

Combination Therapy

Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation

Intervention: Nivolumab

Outcomes

Primary Outcomes

Number of laboratory abnormalities

Time Frame: Approximately 2.2 years

Number of serious adverse events (SAE)

Time Frame: Approximately 2.2 years

Number of deaths

Time Frame: Approximately 2.2 years

Number of adverse events (AE)

Time Frame: Approximately 2.2 years

Secondary Outcomes

Time of maximum observed serum concentration (Tmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Total body clearance (CLT) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Maximum observed serum concentration (Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Frequency of positive anti-drug antibody (ADA) to Nivolumab(Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Trough observed serum concentration (Ctrough) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Concentration at the end of a dosing interval (Ctau) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Volume of distribution at steady state (Vss) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Best overall response (BOR)(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Duration of response (DOR)(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Frequency of positive anti-drug antibody (ADA) to BMS-986016(Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)