An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
- Conditions
- Advanced Cancer
- Registration Number
- NCT03459222
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 255
Inclusion Criteria:<br><br> - Histologic or cytologic confirmation of select incurable solid malignancies that are<br> advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1<br><br> - Available tumor tissue for biomarker analysis<br><br> - Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1<br><br>Exclusion Criteria:<br><br> - Known or suspected central nervous system (CNS) metastases or with the CNS as the<br> only site of active disease<br><br> - History of interstitial lung disease / pneumonitis<br><br> - Prior malignancy active within the previous 2 years except for locally curable<br> cancers that have been cured, such as basal or squamous cell skin cancer<br><br> - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed<br> consent<br><br>Other protocol-defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of clinical laboratory test abnormalities;Number of Adverse Events (AEs);Number of Serious Adverse Events (SAEs);Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria;Number of AEs leading to discontinuation;Number of AEs leading to death;Objective Response Rate (ORR);Disease Control Rate (DCR);Median Duration of Response (mDOR)
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS)