Study Description

Brief summary:

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

• Condition or Disease:Broad Solid Tumor
• Intervention/Treatment: Drug: BMS-986207
  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 27 months ]
  
• Primary Outcome Measures: 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 27 months ]
  
• Primary Outcome Measures: 3. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  
• Primary Outcome Measures: 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 27 months ]
  
• Primary Outcome Measures: 5. Incidence of deaths [ Time Frame: Up to 27 months ]
  
• Primary Outcome Measures: 6. Number of participants with laboratory abnormalities [ Time Frame: Up to 27 months ]
  
• Primary Outcome Measures: 7. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  
• Primary Outcome Measures: 8. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  
• Primary Outcome Measures: 9. Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: At 24 weeks ]
  
• Secondary Outcome Measures: 1. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  
• Secondary Outcome Measures: 2. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  
• Secondary Outcome Measures: 3. Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 [ Time Frame: At 24 Weeks ]
  
• Secondary Outcome Measures: 4. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 27 months ]
  
• Secondary Outcome Measures: 5. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 27 months ]
  
• Secondary Outcome Measures: 6. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) [ Time Frame: Up to 27 months ]
  
• Secondary Outcome Measures: 7. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 27 months ]
  

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: NCT02913313 History of Changes
• Other Study ID Numbers: CA020-002, 2016-002263-34
• First Posted: September 23, 2016 Key Record Dates
• Last Update Posted: April 28, 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: First line NSCLC
• Additional relevant MeSH terms: Neoplasms