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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 : Recruiting
First Posted : September 23, 2016
Last Update Posted : November 19, 2019
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 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

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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

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




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



Information from the National Library of Medicine

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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


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 Active, not recruiting
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 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Charles Schneider, Site 0012         
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 Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0006         
Canada, Ontario
Local Institution Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0008         
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Albiruni 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         
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     History of Changes
Other Study ID Numbers: CA020-002
2016-002263-34 ( EudraCT Number )
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents