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A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With 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: NCT03251924
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 15, 2017
First Posted Date  ICMJE August 16, 2017
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date October 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • Incidence of adverse events (AE) [ Time Frame: Approximately 2 years ]
  • Incidence of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
  • Incidence of AE due to discontinuation [ Time Frame: Approximately 2 years ]
  • Incidence of AE resulting in death [ Time Frame: Approximately 2 years ]
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Approximately 2 years ]
  • Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE) [ Time Frame: Approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • Objective response rate (ORR) measure by Clopper-Pearson method [ Time Frame: Approximately 2 years ]
  • Median Duration of Response (mDOR) measured by Kaplan-Meier method [ Time Frame: Approximately 2 years ]
  • Progression Free Survival (PFS) measured by Kaplan-Meier method [ Time Frame: At 24 weeks ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 2 years ]
  • Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 2 years ]
  • Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)] [ Time Frame: Approximately 2 years ]
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  • Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay [ Time Frame: Approximately 2 years ]
  • Change from baseline in immunoassay for BMS-986226 [ Time Frame: Approximately 2 years ]
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 A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
Brief Summary The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.
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
  • Cancer
  • Tumors
  • Neoplasm
  • Malignancy
Intervention  ICMJE
  • Drug: BMS-986226
    specified dose on specified days
  • Biological: Nivolumab
    specified dose on specified days
    Other Names:
    • BMS-936558
    • PD-1 receptor blocking monoclonal antibody [mAb]
    • Opdivo
  • Biological: Ipilimumab
    specified dose on specified days
    Other Names:
    • BMS-734016
    • MDX010
    • Checkpoint blocking antibody that recognizes CTLA-4
    • Yervoy
  • Biological: Tetanus Vaccine
    specified dose on specified days
Study Arms  ICMJE
  • Experimental: BMS-986226
    administered intravenously
    Interventions:
    • Drug: BMS-986226
    • Biological: Tetanus Vaccine
  • Experimental: BMS-986226 and Nivolumab
    administered intravenously
    Interventions:
    • Drug: BMS-986226
    • Biological: Nivolumab
    • Biological: Tetanus Vaccine
  • Experimental: BMS-986226 and Ipilimumab
    administered intravenously
    Interventions:
    • Drug: BMS-986226
    • Biological: Ipilimumab
    • Biological: Tetanus Vaccine
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: August 6, 2019)
234
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2017)
277
Estimated Study Completion Date  ICMJE May 15, 2023
Estimated Primary Completion Date October 4, 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:

  • Advanced solid tumors
  • Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
  • At least 1 lesion accessible for biopsy in addition to the target lesion
  • Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

  • Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)
  • Participants with carcinomatous meningitis
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
  • Active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease
  • Participants with known allergies to egg products, neomycin and tetanus toxoid.
  • Prior adverse reaction to tetanus toxoid- containing vaccines.

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 Canada,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03251924
Other Study ID Numbers  ICMJE CA021-002
2017-000238-73 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2019

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