Description:
The purpose of this study is to determine whether BMS-986299 both by itself and in
combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced
solid tumors. In addition, the ability of study drugs to stimulate an immune response against
cancer will be investigated.
Title
- Brief Title: An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
- Official Title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Clinical Trial IDs
- ORG STUDY ID:
CA039-001
- NCT ID:
NCT03444753
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BMS-986299 | | Arm A |
Nivolumab | Opdivo, BMS-936558 | Arm B |
Ipilimumab | Yervoy, BMS-734016 | Arm B |
Purpose
The purpose of this study is to determine whether BMS-986299 both by itself and in
combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced
solid tumors. In addition, the ability of study drugs to stimulate an immune response against
cancer will be investigated.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | BMS-986299 | |
Arm B | Experimental | BMS-986299 in combination with nivolumab and ipilimumab | - BMS-986299
- Nivolumab
- Ipilimumab
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically or cytologically confirmed advanced/metastatic solid tumor and
refractory to or intolerant of existing therapy(ies) known to provide clinical benefit
for the condition of the participant
- IO therapy resistant or insensitive tumors
- Have at least 2 tumor lesions accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria:
- Primary CNS malignancy
- Participants with other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
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: | Incidence of dose-limiting toxicities (DLTs) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Maximum observed plasma concentration (Cmax) |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Time of maximum observed plasma concentration (Tmax) |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
March 24, 2020