Clinical trial NCT02913313: A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Broad Solid Tumor
Keywords: First line NSCLC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-09-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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 or significant cardiovascular disease
* Active, known, or suspected autoimmune disease
* NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
measure: Number of Participants Who Died
timeFrame: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
measure: Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities
timeFrame: From first dose (Day 1) and up to 6 weeks
measure: Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
timeFrame: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
measure: Part 2C: Objective Response Rate (ORR)
timeFrame: From first dose (Day 1) and up to 24 weeks
measure: Part 2C: Duration of Response (DOR)
timeFrame: From first dose (Day 1) and up to 24 weeks
measure: Part 2C: Progression Free Survival Rate at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose (Day 1) and up to 24 weeks
measure: Duration of Response
timeFrame: From first dose (Day 1) and up to 24 weeks
measure: Progression Free Survival Rate at Week 24
timeFrame: Week 24
measure: Maximum Observed Concentration (Cmax) of BMS-986207
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Time to Maximum Concentration (Tmax)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Total Body Clearance (CLT)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
timeFrame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
measure: Number of Participants With Positive Anti-BMS-986207-Antibodies Results
timeFrame: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0003
state: New York
city: Philadelphia
country: United States
facility: Local Institution - 0012
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0002
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0009
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Local Institution - 0010
state: Utah
city: Caba
country: Argentina
facility: Local Institution - 0023
state: Ciudad Autónoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0019
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Local Institution - 0022
state: Distrito Federal
city: Nedlands
country: Australia
facility: Local Institution - 0006
state: Western Australia
city: Ottawa
country: Canada
facility: Local Institution - 0008
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0007
state: Ontario
city: Santiago
country: Chile
facility: Local Institution - 0021
state: Metropolitana
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0004
state: Chiba
city: Chuo-ku
country: Japan
facility: Local Institution - 0005
state: Tokyo
city: Bucharest
country: Romania
facility: Local Institution - 0017
city: Cluj
country: Romania
facility: Local Institution - 0016
city: Craiova
country: Romania
facility: Local Institution - 0018
city: Florești
country: Romania
facility: Local Institution - 0015
city: Singapore
country: Singapore
facility: Local Institution - 0020
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: