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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913313
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : April 28, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
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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 18, 2024
Estimated Study Completion Date : February 16, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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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


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0001    551-996-5863      
United States, New York
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Emerson Lim, Site 0003    212-305-5874      
United States, Pennsylvania
University Of Pennsylvania Completed
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Diwakar Davar, Site 0009    111111111111      
United States, Utah
Local Institution - 0010 Active, not recruiting
Salt Lake City, Utah, United States, 84112
Argentina
Local Institution Not yet recruiting
Buenos Aires, Distrito Federal, Argentina, 1119
Contact: Site 0022         
Local Institution Not yet recruiting
Caba, Distrito Federal, Argentina, 1430
Contact: Site 0023         
Local Institution Not yet recruiting
Cordoba, Argentina, 5000
Contact: Site 0019         
Australia, Western Australia
Linear Clinical Research Ltd Completed
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
The Ottawa Hospital Cancer Centre Completed
Ottawa, Ontario, Canada, K1H 8L6
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Albiruni Abdul Razak, Site 0007    41658648003883      
Chile
Local Institution - 0021 Recruiting
Santiago, Metropolitana, Chile, 8420383
Contact: Site 0021         
Japan
National Cancer Center Hospital East Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Toshihiko Doi, Site 0004         
Local Institution - 0005 Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0005         
Romania
Local Institution Not yet recruiting
Bucharest, Romania, 022328
Contact: Site 0017         
Local Institution Not yet recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0016         
Local Institution Not yet recruiting
Craiova, Romania, 200347
Contact: Site 0018         
Local Institution Not yet recruiting
Floresti/ Cluj, Romania, 407280
Contact: Site 0015         
Singapore
Local Institution Not yet recruiting
Singapore, Singapore, 119074
Contact: Site 0020         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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: April 28, 2022
Last Verified: April 2022

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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:
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Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action