A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Cancer
- Registration Number
- JPRN-jRCT2080223608
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Other protocol defined inclusion/exclusion criteria could apply
Exclusion Criteria
Participants with untreated central nervous system (CNS) metastases
Participants with an active, known, or suspected autoimmune disease
Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>pharmacodynamics<br>Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab<br>Incidence of adverse events (AEs) [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab<br>Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab<br>Incidence of death [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab<br>Frequency of laboratory test toxicity grade shifting from baseline [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab<br>Incidence of AEs leading to discontinuation [ Time Frame: Up to two years ]<br>To assess the safety and tolerability of lirilumab in combination with nivolumab
- Secondary Outcome Measures
Name Time Method