Study Description

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

• Condition or Disease:Advanced Cancer
• Intervention/Treatment: Biological: BMS-986249
  Biological: Nivolumab
  Biological: Ipilimumab
• Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 5. Incidence of death [ Time Frame: Up to 4 years ]
  
• Primary Outcome Measures: 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 9. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  
• Primary Outcome Measures: 10. Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 1. Cmax (Maximum observed serum concentration) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 2. Tmax (Time of maximum observed concentration) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 3. 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 ]
  
• Secondary Outcome Measures: 4. AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 5. Ctau (Observed concentration at the end of a dosing interval) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 6. Ctrough (Trough observed concentrations) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 7. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 8. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 9. 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 ]
  
• Secondary Outcome Measures: 10. Total body clearance (CLT) [ Time Frame: Up to 2 years ]
  
• Secondary Outcome Measures: 11. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 12. Duration of response (DOR) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 13. Progression-Free survival (PFS) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 14. Time to response (TTR) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 15. Incidence of Adverse Events (AEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 16. Incidence of Serious Adverse Events (SAEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 17. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 18. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 19. Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 20. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 21. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 22. Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]
  

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.

-->

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03369223 History of Changes
• Other Study ID Numbers: CA030-001, 2018-000416-21
• First Posted: December 11, 2017 Key Record Dates
• Last Update Posted: April 9, 2021
• Last Verified: April 2021
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Physiological Effects of Drugs
  Antibodies, Monoclonal
  Nivolumab Immunologic Factors
  Antineoplastic Agents
  Antibodies