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An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread

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ClinicalTrials.gov Identifier: NCT02913313
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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 : June 26, 2025
Estimated Study Completion Date : June 27, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1A: Dose Escalation Monotherapy (BMS-986207) Drug: BMS-986207
Specified dose on specified days

Experimental: Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab) 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 (BMS-986207) Drug: BMS-986207
Specified dose on specified days

Experimental: Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab) 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 (BMS-986207 + nivolumab + ipilimumab) 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 (BMS-986207 + nivolumab + ipilimumab) 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




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 months ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 15 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 15 months ]
  5. Incidence of deaths [ Time Frame: Up to 15 months ]
  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 15 months ]
  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 15 months ]
  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 15 months ]
  9. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  10. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  11. 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: At 24 Weeks ]
  4. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 15 months ]
  5. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 15 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 15 months ]
  7. Area under the concentration-time curve in one dosing interval AUC(TAU) [ Time Frame: Up to 15 months ]
  8. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 15 months ]
  9. Total body clearance (CLT) [ Time Frame: Up to 15 months ]
  10. Average concentration over a dosing interval (Css-avg) [ Time Frame: Up to 15 months ]
  11. Accumulation Index (AI) [ Time Frame: Up to 15 months ]
  12. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff) [ Time Frame: Up to 15 months ]
  13. Trough observed serum concentrations (Ctrough) [ Time Frame: Up to 15 months ]
  14. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 15 months ]


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.


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participant must consent for pretreatment and on treatment tumor biopsy samples
  • For Part 1C tumor biopsies are optional
  • Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or metastatic setting (Part 2C)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must have received, and progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C)
  • 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/significant heart disease
  • History of chronic hepatitis [except for hepatocellular carcinoma (HCC)]
  • Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply


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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: 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 Completed
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center (Cumc) Completed
New York, New York, United States, 10032
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    412-647-8762      
United States, Utah
Local Institution Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site 0010         
Australia, Western Australia
Local Institution Completed
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Local Institution 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      
Japan
Local Institution Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Site 0004         
Local Institution 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         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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: July 26, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents