A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02913313 |
Recruitment Status :
Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : May 10, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Broad Solid Tumor | Drug: BMS-986207 Biological: Nivolumab Biological: Ipilimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 241 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 30, 2016 |
Estimated Primary Completion Date : | March 19, 2024 |
Estimated Study Completion Date : | February 18, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1A: Dose Escalation Monotherapy |
Drug: BMS-986207
Specified dose on specified days |
Experimental: Part 1B: Dose Escalation Combination Therapy |
Drug: BMS-986207
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A: Expansion Monotherapy |
Drug: BMS-986207
Specified dose on specified days |
Experimental: Part 2B: Expansion Combination Therapy |
Drug: BMS-986207
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 1C: Triplet Cohort |
Drug: BMS-986207
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Part 2C: Triplet Expansion |
Drug: BMS-986207
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
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- Incidence of Adverse Events (AEs) [ Time Frame: Up to 27 months ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 27 months ]
- Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 27 months ]
- Incidence of deaths [ Time Frame: Up to 27 months ]
- Number of participants with laboratory abnormalities [ Time Frame: Up to 27 months ]
- Objective response rate (ORR) [ Time Frame: Up to 36 months ]
- Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
- Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: At 24 weeks ]
- Objective response rate (ORR) [ Time Frame: Up to 36 months ]
- Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
- Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 [ Time Frame: At 24 Weeks ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 27 months ]
- Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 27 months ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) [ Time Frame: Up to 27 months ]
- Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 27 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913313

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02913313 |
Other Study ID Numbers: |
CA020-002 2016-002263-34 ( EudraCT Number ) |
First Posted: | September 23, 2016 Key Record Dates |
Last Update Posted: | May 10, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
First line NSCLC |
Neoplasms Nivolumab Ipilimumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |