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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

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ClinicalTrials.gov Identifier: NCT03444753
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 20, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE March 20, 2018
Estimated Primary Completion Date November 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  • Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]
  • Incidence of clinical laboratory abnormalities [ Time Frame: Approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03444753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • 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 serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  • Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] [ 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 An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
Official Title  ICMJE A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Brief Summary The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Biological: BMS-986299
    Specified dose on specified day
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified day
    Other Names:
    • Yervoy
    • BMS-734016
Study Arms  ICMJE
  • Experimental: Arm A
    BMS-986299
    Intervention: Biological: BMS-986299
  • Experimental: Arm B
    BMS-986299 in combination with nivolumab and ipilimumab
    Interventions:
    • Biological: BMS-986299
    • Biological: Nivolumab
    • Biological: Ipilimumab
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: February 20, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 19, 2021
Estimated Primary Completion Date November 14, 2021   (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:

  • Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • IO therapy resistant or insensitive tumors
  • Have at least 2 tumor lesions accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Primary central nervous system malignancy
  • Participants with other active malignancy requiring concurrent intervention
  • Uncontrolled or significant cardiovascular disease

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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03444753
Other Study ID Numbers  ICMJE CA039-001
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 January 2019

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