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. Number of participants with laboratory abnormalities [ Time Frame: Up to 2.5 years ]
  
• Primary Outcome Measures: 7. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  
• Primary Outcome Measures: 8. Objective Response Rate (ORR) 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. ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 5. Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 6. Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 7. Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 8. Incidence of AEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 9. Incidence of SAEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 10. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 11. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  
• Secondary Outcome Measures: 12. Number of participants with clinical laboratory abnormalities Part 2 of study [ Time Frame: Up to 2.5 years ]
  
• Secondary Outcome Measures: 13. Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]
  

Eligibility Criteria

Information from the National Library of Medicine

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• 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: May 3, 2022
• Last Verified: April 2022
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Antibodies
  Antineoplastic Agents
  Immunologic Factors Nivolumab
  Antibodies, Monoclonal
  Physiological Effects of Drugs