A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
- Conditions
- Advanced Cancer
- Interventions
- Biological: LirilumabBiological: NivolumabBiological: Ipilimumab
- Registration Number
- NCT03203876
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2 Combination Therapy Lirilumab Lirilumab, Nivolumab and Ipilimumab Part 2 Combination Therapy Nivolumab Lirilumab, Nivolumab and Ipilimumab Part 2 Combination Therapy Ipilimumab Lirilumab, Nivolumab and Ipilimumab Part One Combination Therapy Lirilumab Lirilumab and Nivolumab Part One Combination Therapy Nivolumab Lirilumab and Nivolumab
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of death Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of dose-limiting toxicity (DLT) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of adverse events (AEs) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of AEs leading to discontinuation Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
Frequency of laboratory test toxicity grade shifting from baseline Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab
- Secondary Outcome Measures
Name Time Method Maximum serum observed concentration (Cmax) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Incidence of dose-limiting toxicity (DLT) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Half-life (T-HALF) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Incidence of anti-drug antibody (ADA) Up to two years To characterize immunogenicity
Volume of distribution at steady state (Vss) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Frequency of laboratory test toxicity grade shifting from baseline Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Time of maximum observed serum concentration (Tmax) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Best overall response (BOR) Up to two years To assess the preliminary anti-tumor activity
Duration of response (DOR) Up to two years To assess the preliminary anti-tumor activity
Incidence of serious adverse events (SAEs) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Incidence of death Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)] Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Trough observed serum concentration (Ctrough) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Incidence of adverse events (AEs) Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Clearance (CL) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Ratio of an exposure measure at steady-state to that after the first dose (AI) Up to two years To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Incidence of AEs leading to discontinuation Up to two years To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Trial Locations
- Locations (1)
Local Institution
🇯🇵Kobe-shi, Hyogo, Japan