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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Relatlimab
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |