Description:
The purpose of this study is to evaluate the safety and effectiveness of experimental
medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both
nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
Title
- Brief Title: An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread
- Official Title: Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA020-002
- SECONDARY ID:
2016-002263-34
- NCT ID:
NCT02913313
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BMS-986207 | | Part 1A: Dose Escalation Monotherapy (BMS-986207) |
Nivolumab | BMS-936558, Opdivo | Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab) |
Ipilimumab | BMS-734016, Yervoy | Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab) |
Purpose
The purpose of this study is to evaluate the safety and effectiveness of experimental
medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both
nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1A: Dose Escalation Monotherapy (BMS-986207) | Experimental | | |
Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab) | Experimental | | |
Part 2A: Expansion Monotherapy (BMS-986207) | Experimental | | |
Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab) | Experimental | | |
Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab) | Experimental | | - BMS-986207
- Nivolumab
- Ipilimumab
|
Part 2C: Triplet Expansion (BMS-986207 + nivolumab + ipilimumab) | Experimental | | - BMS-986207
- Nivolumab
- Ipilimumab
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Participant must consent for pretreatment and on treatment tumor biopsy samples
- For Part 1C tumor biopsies are optional
- Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or
metastatic setting (Part 2C)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must have received, and progressed or been intolerant to, at least 1 standard
treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C)
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic
tumor assessment performed within 28 days before randomization
Exclusion Criteria:
- Primary central nervous system (CNS) disease, or tumors with CNS metastases as the
only site of disease. Controlled brain metastases will be allowed to enroll
- Other active malignancy requiring concurrent intervention
- Uncontrolled/significant heart disease
- History of chronic hepatitis [except for hepatocellular carcinoma (HCC)]
- 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 15 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Median duration of response (mDOR) |
Time Frame: | Up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Time Frame: | At 24 Weeks |
Safety Issue: | |
Description: | |
Measure: | Maximum observed serum concentration (Cmax) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Time of maximum observed serum concentration (Tmax) |
Time Frame: | Up to 15 months |
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: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Area under the concentration-time curve in one dosing interval AUC(TAU) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Observed concentration at the end of a dosing interval (Ctau) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Total body clearance (CLT) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Average concentration over a dosing interval (Css-avg) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Accumulation Index (AI) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Trough observed serum concentrations (Ctrough) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-drug antibody (ADA) |
Time Frame: | Up to 15 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 26, 2021