Advanced Cancer
Conditions
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
Interventions
BIOLOGICALLirilumab
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
BIOLOGICALIpilimumab
Specified dose on specified days
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| Incidence of AEs leading to discontinuation | Up to two years | To assess the safety and tolerability of lirilumab in combination with nivolumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed serum concentration (Tmax) | Up to two years | To characterize the PK of lirilumab given in combination with nivolumab |
| 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 |
| 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 |
| Trough observed serum concentration (Ctrough) | Up to two years | To characterize the PK of lirilumab given in combination with nivolumab |
| 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 |
| Clearance (CL) | Up to two years | To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab |
| Volume of distribution at steady state (Vss) | Up to two years | To characterize the PK of lirilumab given 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 and ipilimumab |
| Half-life (T-HALF) | Up to two years | To characterize the PK of lirilumab given in combination with nivolumab |
| 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 |
| 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 anti-drug antibody (ADA) | Up to two years | To characterize immunogenicity |
| Incidence of AEs leading to discontinuation | Up to two years | To assess the safety and tolerability of lirilumab 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 |
| Incidence of adverse events (AEs) | Up to two years | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab |
| 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 |
| 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 |
| Maximum serum observed concentration (Cmax) | Up to two years | To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab |
Countries
Japan
Outcome results
None listed