Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
![]() |
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: NCT02966548 |
Recruitment Status :
Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : January 11, 2023
|
Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 1, 2016 | |||
First Posted Date ICMJE | November 17, 2016 | |||
Last Update Posted Date | January 11, 2023 | |||
Actual Study Start Date ICMJE | January 4, 2017 | |||
Estimated Primary Completion Date | September 8, 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors | |||
Official Title ICMJE | A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors | |||
Brief Summary | This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Cancer | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
35 | |||
Original Estimated Enrollment ICMJE |
27 | |||
Estimated Study Completion Date ICMJE | September 8, 2023 | |||
Estimated Primary Completion Date | September 8, 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply |
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02966548 | |||
Other Study ID Numbers ICMJE | CA224-034 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Bristol-Myers Squibb | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Bristol-Myers Squibb | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Ono Pharmaceutical Co. Ltd | |||
Investigators ICMJE |
|
|||
PRS Account | Bristol-Myers Squibb | |||
Verification Date | January 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |