We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in 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: NCT02913313
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : May 10, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Broad Solid Tumor Drug: BMS-986207 Biological: Nivolumab Biological: Ipilimumab Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • BMS-936558
  • Opdivo
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:
  • BMS-936558
  • Opdivo
Experimental: Part 1C: Triplet Cohort Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 2C: Triplet Expansion Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 27 months ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 27 months ]
  3. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 27 months ]
  5. Incidence of deaths [ Time Frame: Up to 27 months ]
  6. Number of participants with laboratory abnormalities [ Time Frame: Up to 27 months ]
  7. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  8. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  9. 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 ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  2. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  3. Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 [ Time Frame: At 24 Weeks ]
  4. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 27 months ]
  5. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 27 months ]
  6. 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 ]
  7. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 27 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 20 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
First line NSCLC
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action