Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
- Registration Number
- NCT02966548
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy Relatlimab Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation Monotherapy Relatlimab Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation Combination Therapy Nivolumab Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
- Primary Outcome Measures
Name Time Method Number of laboratory abnormalities Approximately 2.2 years Number of serious adverse events (SAE) Approximately 2.2 years Number of deaths Approximately 2.2 years Number of adverse events (AE) Approximately 2.2 years
- Secondary Outcome Measures
Name Time Method 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 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 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 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
Trial Locations
- Locations (1)
Local Institution - 0001
🇯🇵Kashiwa-shi, Chiba, Japan