An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03400332 |
Recruitment Status :
Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : June 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cancer | Drug: BMS-986253 Biological: Nivolumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers |
Actual Study Start Date : | January 31, 2018 |
Estimated Primary Completion Date : | November 26, 2023 |
Estimated Study Completion Date : | November 26, 2023 |

Arm | Intervention/treatment |
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Experimental: Dose Finding
BMS-986253 administered in combination with Nivolumab
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Drug: BMS-986253
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Dose Expansion
BMS-986253 administered in combination with Nivolumab
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Drug: BMS-986253
Specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
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- Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
- Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
- Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
- Incidence of deaths [ Time Frame: Approximately 5 years ]
- Incidence of labornatory abnormalities [ Time Frame: Approximately 5 years ]
- Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
- Median duration of response (mDOR) [ Time Frame: Approximately 5 years ]
- Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
- Serum biomarker concentration [ Time Frame: Approximately 5 years ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
- Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
- Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
- Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
- Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria:
- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Other protocol defined inclusion/exclusion criteria could 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): NCT03400332

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03400332 |
Other Study ID Numbers: |
CA027-002 |
First Posted: | January 17, 2018 Key Record Dates |
Last Update Posted: | June 22, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents |