A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

Incidence of serious adverse events (SAEs)

To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

Time frame: Up to two years

Incidence of death

To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

Time frame: Up to two years

Frequency of laboratory test toxicity grade shifting from baseline

To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

Time frame: Up to two years

Maximum serum observed concentration (Cmax)

To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab

Time frame: Up to two years

Time of maximum observed serum concentration (Tmax)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Trough observed serum concentration (Ctrough)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Clearance (CL)

To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab

Time frame: Up to two years

Volume of distribution at steady state (Vss)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Ratio of an exposure measure at steady-state to that after the first dose (AI)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Half-life (T-HALF)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)

To characterize the PK of lirilumab given in combination with nivolumab

Time frame: Up to two years

Best overall response (BOR)

To assess the preliminary anti-tumor activity

Time frame: Up to two years

Duration of response (DOR)

To assess the preliminary anti-tumor activity

Time frame: Up to two years

Incidence of anti-drug antibody (ADA)

To characterize immunogenicity

Time frame: Up to two years

Incidence of AEs leading to discontinuation

To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

Time frame: Up to two years

Maximum serum observed concentration (Cmax)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Time of maximum observed serum concentration (Tmax)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Trough observed serum concentration (Ctrough)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Clearance (CL)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Volume of distribution at steady state (Vss)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Ratio of an exposure measure at steady-state to that after the first dose (AI)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Half-life (T-HALF)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years

Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)

To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

Time frame: Up to two years