Description:
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental
medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers
that are advanced or have spread.
Title
- Brief Title: An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
- Official Title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA013-004
- SECONDARY ID:
2016-000603-91
- NCT ID:
NCT02754141
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986179 | | Arm A-Monotherapy |
| Nivolumab | BMS-936558, Opdivo | Arm B- Combination Therapy |
| rHuPH20 | | Arm C-Combination Therapy |
Purpose
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental
medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers
that are advanced or have spread.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A-Monotherapy | Experimental | BMS-986179, dose as specified | |
| Arm B- Combination Therapy | Experimental | BMS-986179 + nivolumab, dose as specified | |
| Arm C-Combination Therapy | Experimental | BMS-986179 + rHuPH20, dose as specified | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Solid cancers that are advanced or have spread (for which alternative therapies were
deemed not effective)
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Acceptable lab testing results
- Allow biopsies
Exclusion Criteria:
- Central nervous system (CNS) tumors
- Uncontrolled or significant cardiovascular diseases
- Active or known autoimmune disease
- Organ transplant
Other protocol defined inclusion/exclusion criteria could apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies |
| Time Frame: | Approximately 63 days |
| Safety Issue: | |
| Description: | |
| Measure: | The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies |
| Time Frame: | Approximately 63 days |
| Safety Issue: | |
| Description: | |
| Measure: | Objective response rate (ORR) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival rate (PFSR) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent terminal half-life (T-HALF) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Effective elimination half-life (T-HALFeff) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Concentration at the end of the dosing interval (Ctau) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentration at the end of the dosing interval (Ctrough) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Total body clearance (CLT) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Volume of distribution at steady state (Vss) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Accumulation index (AI) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Apparent volume of distribution of terminal phase (Vz) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Degree of fluctuation or fluctuation index (DF) |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Frequency of positive anti-drug antibody (ADA) to BMS-986179 |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
| Measure: | Frequency of positive anti-drug antibody (ADA) to nivolumab |
| Time Frame: | Up to 100 days after the last dose of study drug |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
February 16, 2021
