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An Investigational Immuno-therapy Study to Evaluate the Safety and Effectiveness of Experimental Medication BMS-986207 by Itself and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

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ClinicalTrials.gov Identifier: NCT02913313
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : August 10, 2020
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 and in combination with Nivolumab in solid cancers that are advanced or have spread.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 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 in Advanced Solid Tumors
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 16, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1A- Dose Escalation- Monotherapy
Specified dose on specified days
 Drug: BMS-986207
Experimental: Part 1B- Dose Escalation- Combination Therapy
Specified dose on specified days
 Drug: BMS-986207
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Part 2A- Expansion- Monotherapy
Specified dose on specified days
 Drug: BMS-986207
Experimental: Part 2B- Expansion- Combination Therapy
Specified dose on specified days
 Drug: BMS-986207
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events of BMS-986207 [ Time Frame: Up to 15 months ]
  2. Incidence of adverse events of nivolumab (BMS-936558) and BMS-986207 when given in combination [ Time Frame: Up to 15 months ]
  3. Incidence of clinically significant abnormalities in general laboratory tests of BMS-986207 [ Time Frame: Up to 15 months ]
  4. Incidence of clinically significant abnormalities in general laboratory tests of nivolumab(BMS-936558) and BMS-986207 when given in combination [ Time Frame: Up to 15 months ]

Secondary Outcome Measures :
  1. Best Overall Response (BOR) [ Time Frame: Up to 36 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
  3. median Duration of Response (mDOR) [ Time Frame: Up to 36 months ]
  4. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 36 months ]
  5. Maximum observed plasma concentration (Cmax) of BMS-986207 [ Time Frame: Up to 15 months ]
  6. Time of maximum observed plasma concentration (Tmax) of BMS-986207 [ Time Frame: Up to 15 months ]
  7. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)] of BMS-986207 [ Time Frame: Up to 15 months ]
  8. Trough observed plasma concentration (Ctrough) of BMS-986207 [ Time Frame: Up to 15 months ]
    Includes pre-dose concentrations [C0] and Ctau

  9. Area under the concentration-time curve in one dosing interval [AUC(tau)] of BMS-986207 [ Time Frame: Up to 15 months ]
  10. Total body clearance (CLT) of BMS-986207 [ Time Frame: Up to 15 months ]
  11. Observed concentration at the end of a dosing interval (Ctau) of BMS-986207 [ Time Frame: Up to 15 months ]
  12. Effective elimination half-life (T-HALFeff) of BMS-986207 [ Time Frame: Up to 15 months ]
    explains degree of accumulation observed for a specific exposure measure [exposure measure includes AUC(tau)] derived from serum concentration versus time data

  13. Accumulation Index (AI) of BMS-986207 [ Time Frame: Up to 15 months ]
    Ratio of exposure measure at steady state to that after the first dose (exposure measure includes AUC[tau]) derived from serum concentration versus time data).

  14. Average concentration of BMS-986207 over a dosing interval [ Time Frame: Up to 15 months ]
    Css-avg= AUC[TAU]/tau

  15. Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207 [ Time Frame: Up to 15 months ]
  16. Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207 in combination with nivolumab (BMS-936558) [ Time Frame: Up to 15 months ]
  17. Tumor infiltrating lymphocyte (TIL) evaluations for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  18. Serum cytokines profiling for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  19. Serum proteome analysis for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  20. Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  21. Tumor-specific immune cells for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  22. Tumor infiltrating lymphocyte (TIL) evaluations for BMS-986207 in combination with nivolumab (BMS-936558) [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  23. Serum cytokines profiling for BMS-986207 in combination with nivolumab (BMS-936558) [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  24. Serum proteome analysis for BMS-986207 in combination with nivolumab(BMS-936558) [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  25. Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207 in combination with nivolumab (BMS-936558) [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured

  26. Tumor-specific immune cells for BMS-986207 in combination with nivolumab(BMS-936558) [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured


Eligibility Criteria
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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:

  • Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must have received and progressed on or failed one standard/approved treatment for cancer type, if available
  • At least 4 weeks since any previous treatment for cancer
  • Subject must consent to pretreatment and on treatment tumor biopsies
  • At least one lesion with measurable disease at baseline
  • Adequate organ and marrow function

Exclusion Criteria:

  • Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
  • Prior organ transplant
  • Participants with second/other active cancers requiring current treatment
  • Uncontrolled/significant heart disease
  • History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
  • Active/uncontrolled autoimmune disease
  • Active infection

Other protocol defined inclusion/exclusion criteria could 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


Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center (Cumc)
New York, New York, United States, 10032
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
Local Institution
Salt Lake City, Utah, United States, 84112
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Japan
Local Institution
Kashiwa-shi, Chiba, Japan, 2778577
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
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: August 10, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents