Description:
The purpose of this study is to determine whether BMS-986249 both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Title
- Brief Title: An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread
- Official Title: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA030-001
- SECONDARY ID:
2018-000416-21
- NCT ID:
NCT03369223
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986249 | | Part 1A: BMS-986249 |
| Nivolumab | Opdivo, BMS-936558 | Part 1B: BMS-986249 + nivolumab (nivo) |
| Ipilimumab | Yervoy, BMS 734016 | Part 2A Arm D: ipilimumab + nivo then nivo |
Purpose
The purpose of this study is to determine whether BMS-986249 both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1A: BMS-986249 | Experimental | | |
| Part 1B: BMS-986249 + nivolumab (nivo) | Experimental | | |
| Part 2A Arm C: BMS-986249 + nivo | Experimental | Previously untreated unresectable stage III-IV melanoma | |
| Part 2A Arm D: ipilimumab + nivo then nivo | Experimental | Previously untreated unresectable stage III-IV melanoma | |
| Part 2A Arm F: BMS-986249 + nivo | Experimental | Previously untreated unresectable stage III-IV melanoma | |
| Part 2B Cohort 1: BMS-986249 + nivo | Experimental | Advanced hepatocellular carcinoma (HCC) | |
| Part 2B Cohort 2: BMS-986249 + nivo | Experimental | Metastatic castration-resistant prostate cancer (CRPC) | |
| Part 2B Cohort 3: BMS-986249 + nivo | Experimental | Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) | |
| Part 2A Arm A: BMS-986249 + nivo then nivo | Experimental | Previously untreated unresectable stage III-IV melanoma
Enrollment is closed for this Arm | |
| Part 2A Arm B: BMS-986249 + nivo | Experimental | Previously untreated unresectable stage III-IV melanoma
Enrollment is closed for this Arm | |
| Part 2A Arm E: Nivo | Experimental | Previously untreated unresectable stage III-IV melanoma
Enrollment is closed for this Arm | |
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 and have at least 1 lesion
accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Some participants must have received, and then progressed, relapsed, or been
intolerant to, at least 1 standard treatment regimen in the advanced or metastatic
setting according to solid tumor histologies
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are
permitted for some participants
- Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Primary CNS malignancies, tumors with CNS metastases as the only site of disease or
active brain metastases will be excluded
- Other active malignancy requiring concurrent intervention
- Prior organ allograft
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria 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 (AEs) |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Cmax (Maximum observed serum concentration) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Tmax (Time of maximum observed concentration) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ctau (Observed concentration at the end of a dosing interval) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ctrough (Trough observed concentrations) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Terminal serum half-life if data permit (T-HALF) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Total body clearance (CLT) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-Free survival (PFS) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to response (TTR) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Adverse Events (AEs) in Part 2 of Study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Serious Adverse Events (SAEs) in Part 2 of Study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of AEs leading to discontinuation in Part 2 of study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of death in Part 2 of study |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Deterioration (TTD) in Part 2 of study |
| Time Frame: | Up to 4 Years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- Antibodies
- Antineoplastic Agents
- Immunologic Factors
- Nivolumab
- Antibodies, Monoclonal
- Physiological Effects of Drugs
Last Updated
April 9, 2021
