Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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:
|
| 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: Relatlimab
Specified dose on specified days
Other Names:
Drug: Nivolumab
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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)
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Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
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Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
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Males and Females, ages 20 years or older, inclusive
Exclusion Criteria:
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Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
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Other concomitant malignancies (with some exceptions per protocol)
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Any active autoimmune disease or history of known or suspected autoimmune disease
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History of uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Kashiwa-shi | Chiba | Japan | 2778577 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- CA224-034