Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Nivolumab; Drug: Relatlimab

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 2778577
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy; Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation	Drug: Relatlimab; Specified dose on specified days; Other Names: BMS-986016
Experimental: Combination Therapy; Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation	Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Relatlimab; Specified dose on specified days; Other Names: BMS-986016

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AE)	Approximately 2.2 years
Number of serious adverse events (SAE)	Approximately 2.2 years
Number of deaths	Approximately 2.2 years
Number of laboratory abnormalities	Approximately 2.2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Estimated): July 5, 2024
• Study Completion (Estimated): July 4, 2025

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimated): November 17, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Relatlimab
• Other Study ID Numbers: CA224-034