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NCT02966548 Clinical Trial

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

Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02966548
Other study ID # CA224-034
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date January 4, 2017
Est. completion date July 4, 2025

Study information
Verified date January 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 35
Est. completion date July 4, 2025
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Relatlimab
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations
Country Name City State
Japan Local Institution - 0001 Kashiwa-shi Chiba

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events (AE) Approximately 2.2 years
Primary Number of serious adverse events (SAE) Approximately 2.2 years
Primary Number of deaths Approximately 2.2 years
Primary Number of laboratory abnormalities Approximately 2.2 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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