Description:
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.
Title
- Brief Title: Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
- 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 IDs
- ORG STUDY ID:
CA224-034
- NCT ID:
NCT02966548
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Relatlimab | BMS-986016 | Combination Therapy |
| Nivolumab | BMS-936558, Opdivo | Combination Therapy |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Monotherapy | Experimental | Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation | |
| Combination Therapy | Experimental | Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation | |
Eligibility 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)
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of adverse events (AE) |
| Time Frame: | Approximately 2.2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Maximum observed serum concentration (Cmax) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentration (Ctrough) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Concentration at the end of a dosing interval (Ctau) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Total body clearance (CLT) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Volume of distribution at steady state (Vss) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Best overall response (BOR) |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) |
| Time Frame: | Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Frequency of positive anti-drug antibody (ADA) to BMS-986016 |
| Time Frame: | Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
| Measure: | Frequency of positive anti-drug antibody (ADA) to Nivolumab |
| Time Frame: | Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 5, 2020
