A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
- Conditions
- Broad Solid Tumor
- Interventions
- Drug: BMS-986207Biological: NivolumabBiological: Ipilimumab
- Registration Number
- NCT02913313
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1C: Triplet Cohort Ipilimumab - Part 2C: Triplet Expansion Ipilimumab - Part 2A: Expansion Monotherapy BMS-986207 - Part 1C: Triplet Cohort BMS-986207 - Part 2B: Expansion Combination Therapy Nivolumab - Part 2B: Expansion Combination Therapy BMS-986207 - Part 1C: Triplet Cohort Nivolumab - Part 1B: Dose Escalation Combination Therapy BMS-986207 - Part 1B: Dose Escalation Combination Therapy Nivolumab - Part 1A: Dose Escalation Monotherapy BMS-986207 - Part 2C: Triplet Expansion BMS-986207 - Part 2C: Triplet Expansion Nivolumab -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 27 months Incidence of deaths Up to 27 months Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria Up to 6 weeks Incidence of AEs leading to discontinuation Up to 27 months Objective response rate (ORR) Up to 36 months Incidence of Serious Adverse Events (SAEs) Up to 27 months Number of participants with laboratory abnormalities Up to 27 months Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator At 24 weeks Median duration of response (mDOR) Up to 36 months
- Secondary Outcome Measures
Name Time Method Median duration of response (mDOR) Up to 36 months Time of maximum observed serum concentration (Tmax) Up to 27 months Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 At 24 Weeks Objective response rate (ORR) Up to 36 months Maximum observed serum concentration (Cmax) Up to 27 months Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) Up to 27 months Incidence of anti-drug antibody (ADA) Up to 27 months
Trial Locations
- Locations (20)
Local Institution - 0015
🇷🇴Florești, Romania
Local Institution - 0003
🇺🇸New York, New York, United States
Local Institution - 0010
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0001
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0012
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0007
🇨🇦Toronto, Ontario, Canada
Local Institution - 0004
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0005
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0002
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0009
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0023
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0019
🇦🇷Córdoba, Cordoba, Argentina
Local Institution - 0020
🇸🇬Singapore, Singapore
Local Institution - 0006
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0016
🇷🇴Cluj, Romania
Local Institution - 0021
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0022
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0017
🇷🇴Bucharest, Romania
Local Institution - 0018
🇷🇴Craiova, Romania
Local Institution - 0008
🇨🇦Ottawa, Ontario, Canada