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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

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE November 29, 2016
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Incidence of adverse events of BMS-986207 [ Time Frame: Up to 15 months ]
  • Incidence of adverse events of nivolumab (BMS-936558) and BMS-986207 when given in combination [ Time Frame: Up to 15 months ]
  • Incidence of clinically significant abnormalities in general laboratory tests of BMS-986207 [ Time Frame: Up to 15 months ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Best Overall Response (BOR) [ Time Frame: Up to 36 months ]
  • Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
  • median Duration of Response (mDOR) [ Time Frame: Up to 36 months ]
  • Progression Free Survival Rate (PFSR) [ Time Frame: Up to 36 months ]
  • Maximum observed plasma concentration (Cmax) of BMS-986207 [ Time Frame: Up to 15 months ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-986207 [ Time Frame: Up to 15 months ]
  • 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 ]
  • Trough observed plasma concentration (Ctrough) of BMS-986207 [ Time Frame: Up to 15 months ]
    Includes pre-dose concentrations [C0] and Ctau
  • Area under the concentration-time curve in one dosing interval [AUC(tau)] of BMS-986207 [ Time Frame: Up to 15 months ]
  • Total body clearance (CLT) of BMS-986207 [ Time Frame: Up to 15 months ]
  • Observed concentration at the end of a dosing interval (Ctau) of BMS-986207 [ Time Frame: Up to 15 months ]
  • 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
  • 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).
  • Average concentration of BMS-986207 over a dosing interval [ Time Frame: Up to 15 months ]
    Css-avg= AUC[TAU]/tau
  • Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207 [ Time Frame: Up to 15 months ]
  • 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 ]
  • Tumor infiltrating lymphocyte (TIL) evaluations for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured
  • Serum cytokines profiling for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured
  • Serum proteome analysis for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured
  • 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
  • Tumor-specific immune cells for BMS-986207 [ Time Frame: Up to 6 months ]
    This is how the pharmacodynamic activity will be measured
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Broad Solid Tumor
Intervention  ICMJE
  • Drug: BMS-986207
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • Opdivo
Study Arms  ICMJE
  • Experimental: Part 1A- Dose Escalation- Monotherapy
    Specified dose on specified days
    Intervention: Drug: BMS-986207
  • Experimental: Part 1B- Dose Escalation- Combination Therapy
    Specified dose on specified days
    Interventions:
    • Drug: BMS-986207
    • Biological: Nivolumab
  • Experimental: Part 2A- Expansion- Monotherapy
    Specified dose on specified days
    Intervention: Drug: BMS-986207
  • Experimental: Part 2B- Expansion- Combination Therapy
    Specified dose on specified days
    Interventions:
    • Drug: BMS-986207
    • Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 16, 2022
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913313
Other Study ID Numbers  ICMJE CA020-002
2016-002263-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP