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An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

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: NCT03369223
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE December 5, 2017
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Incidence of Adverse Events (AE) [ Time Frame: up to 2.5 years ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 2.5 years ]
  • Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: up to 2.5 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: up to 2.5 years ]
  • Incidence of death [ Time Frame: up to 2.5 years ]
  • Incidence of Laboratory abnormalities [ Time Frame: up to 4 years ]
  • Incidence of treatment-related Grade 3-5 AEs [ Time Frame: At 24 weeks ]
  • Objective Response Rate as assessed by investigator using (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 [ Time Frame: up to 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Incidence of Adverse Events (AE) [ Time Frame: up to 4 years ]
    Safety and tolerability as measured by incidence of AEs
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 4 years ]
    Safety and tolerability as measured by incidence of AEs
  • Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: up to 4 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: up to 4 years ]
  • Incidence of death [ Time Frame: up to 4 years ]
  • Incidence of Laboratory abnormalities [ Time Frame: up to 4 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Cmax (Maximum observed serum concentration) of BMS-986249 [ Time Frame: up to 2 years ]
  • Tmax (Time of maximum observed concentration) of BMS-986249 [ Time Frame: up to 2 years ]
  • AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) of BMS-986249 [ Time Frame: up to 2 years ]
  • AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) of BMS-986249 [ Time Frame: up to 2 years ]
  • Ctau (Observed concentration at the end of a dosing interval) of BMS-986249 [ Time Frame: up to 2 years ]
  • Ctrough (Trough observed concentrations) of BMS-986249 [ Time Frame: up to 2 years ]
  • Objective Response Rate (ORR) [ Time Frame: up to 4 years ]
  • Duration of response (DOR) [ Time Frame: up to 4 years ]
  • Progression-Free survival (PFS) [ Time Frame: up to 4 years ]
  • Time to response (TTR) [ Time Frame: up to 4 years ]
  • Total body clearance (CLT) of BMS-986249 [ Time Frame: up to 2 years ]
  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) of BMS-986249 [ Time Frame: up to 2 years ]
  • Terminal serum half-life if data permit (T-HALF) of BMS-986249 [ Time Frame: up to 2 years ]
  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] of BMS-986249 [ Time Frame: up to 2 years ]
  • Incidence of Adverse Events (AE) in Part 2 of Study [ Time Frame: up to 2.5 years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: up to 2.5 years ]
  • Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: up to 2.5 years ]
  • Incidence of Deaths [ Time Frame: up to 2.5 years ]
  • Incidence of laboratory abnormalities [ Time Frame: up to 4 years ]
  • Time to Deterioration (TTD) [ Time Frame: up to 4 Years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Cmax (Maximum observed serum concentration) [ Time Frame: up to 2 years ]
  • Tmax (Time of maximum observed concentration) [ Time Frame: up to 2 years ]
  • AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: up to 2 years ]
  • AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) [ Time Frame: up to 2 years ]
  • Ctau (Observed concentration at the end of a dosing interval) [ Time Frame: up to 2 years ]
  • Ctrough (Trough observed concentrations) [ Time Frame: up to 2 years ]
  • Best overall response (BOR) [ Time Frame: up to 4 years ]
    assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Duration of response (DOR) [ Time Frame: up to 4 years ]
  • Progression-Free survival (PFS) [ Time Frame: up to 4 years ]
  • Time to response (TTR) [ Time Frame: up to 4 years ]
  • Total body clearance (CLT) [ Time Frame: up to 2 years ]
  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: up to 2 years ]
  • Terminal serum half-life if data permit (T-HALF) [ Time Frame: up to 2 years ]
  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: up to 2 years ]
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-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread
Official Title  ICMJE A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Brief Summary The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Biological: BMS-986249
    specified dose on specified day
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS 734016
Study Arms  ICMJE
  • Experimental: Part 1A: BMS-986249
    Intervention: Biological: BMS-986249
  • Experimental: Part 1B: BMS-986249+nivolumab (nivo)
    Interventions:
    • Biological: BMS-986249
    • Biological: Nivolumab
  • Experimental: Part 2A Arm A: BMS-986249+nivo then nivo
    Interventions:
    • Biological: BMS-986249
    • Biological: Nivolumab
  • Experimental: Part 2A Arm B: BMS-986249+nivo
    Interventions:
    • Biological: BMS-986249
    • Biological: Nivolumab
  • Experimental: Part 2A Arm C: BMS-986249+nivo
    Interventions:
    • Biological: BMS-986249
    • Biological: Nivolumab
  • Experimental: Part 2A Arm D: ipilimumab+nivo then nivo
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Part 2A Arm E: Nivo
    Intervention: 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: June 25, 2019)
375
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
300
Estimated Study Completion Date  ICMJE July 15, 2024
Estimated Primary Completion Date October 30, 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:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients
  • Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease, active brain metastases, or leptomeningeal metastasis will be excluded
  • Active, known, or suspected autoimmune disease
  • Participants with other active malignancy requiring concurrent intervention.
  • Prior organ allograft.

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,   Germany,   Italy,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03369223
Other Study ID Numbers  ICMJE CA030-001
2018-000416-21 ( 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 February 2020

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