Description:
The purpose of this study is to investigate experimental medication BMS-986253 in combination
with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Title
- Brief Title: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
- Official Title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Clinical Trial IDs
- ORG STUDY ID:
CA027-002
- SECONDARY ID:
2018-000340-26
- NCT ID:
NCT03400332
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986253 | | Part 1A: BMS-986253 + nivolumab |
| Nivolumab | BMS-936558, Opdivo | Part 1A: BMS-986253 + nivolumab |
| Ipilimumab | BMS-734016, YERVOY | Part 1C: BMS-986253 + nivolumab + ipilimumab |
Purpose
The purpose of this study is to investigate experimental medication BMS-986253 in combination
with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1A: BMS-986253 + nivolumab | Experimental | | |
| Part 1B: BMS-986253 + nivolumab | Experimental | | |
| Part 1C: BMS-986253 + nivolumab + ipilimumab | Experimental | | - BMS-986253
- Nivolumab
- Ipilimumab
|
| Part 2A: BMS-986253 + nivolumab + ipilimumab | Experimental | | - BMS-986253
- Nivolumab
- Ipilimumab
|
| Part 2B: Placebo + nivolumab + ipilimumab | Placebo Comparator | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,
recurrent and/or unresectable) with measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria:
- Participants with CNS metastases as the only site of active disease (Participants with
controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids
(> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days
of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus
(HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
anti-cancer therapy and initiation of study therapy
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 adverse events (AE) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 |
Secondary Outcome Measures
| Measure: | Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 |
| Measure: | Incidence of anti-drug antibody (ADA) to BMS-986253 |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Serum biomarker concentration |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 |
| Measure: | Maximum observed serum concentration (Cmax) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Time of maximum observed serum concentration (Tmax) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Observed serum concentration at the end of a dosing interval (CTAU) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Trough observed serum concentration at the end of the dosing interval (CTROUGH) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 1 and Part 2 |
| Measure: | Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels) |
| Measure: | Overall Survival (OS) |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of AEs |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of SAEs |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of AEs leading to discontinuation |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of death |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |
| Time Frame: | Approximately 5 years |
| Safety Issue: | |
| Description: | Part 2 |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 11, 2021
