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

A Phase 1 Study of the Safety and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination with Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab,BMS-734016) in Advanced and/or Metastatic Solid Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223608

Enrollment

Registered

2017-08-02

Start date

2017-07-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Interventions

investigational material(s) Generic name etc : BMS-986015 (lirilumab) INN of investigational material : Lirilumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics pharmacodynamics Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of adverse events (AEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of death [ Time Frame: 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 [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of AEs leading to discontinuation [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab	—

Measure

Time frame

safety pharmacokinetics pharmacodynamics Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of adverse events (AEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of death [ Time Frame: 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 [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab Incidence of AEs leading to discontinuation [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab

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Secondary

Measure	Time frame
efficacy Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of adverse events (AEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of death [ Time Frame: 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 [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Maximum serum observed concentration (Cmax) [ Time Frame: Up to two years ] To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab Time of maximum observed serum concentration (Tmax) [ Time Frame: 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)] [ Time Frame: 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)] [ Time Frame: Up to two years ] To characterize the PK of lirilumab given in combination with nivolumab Trough observed serum concentration (Ctrough) [ Time Frame: 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)] [ Time Frame: Up to two years ] To characterize the PK of lirilumab given in combination with nivolumab Clearance (CL) [ Time Frame: Up to two years ] To characteri	—

Measure

Time frame

efficacy Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of adverse events (AEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Incidence of death [ Time Frame: 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 [ Time Frame: Up to two years ] To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab Maximum serum observed concentration (Cmax) [ Time Frame: Up to two years ] To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab Time of maximum observed serum concentration (Tmax) [ Time Frame: 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)] [ Time Frame: 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)] [ Time Frame: Up to two years ] To characterize the PK of lirilumab given in combination with nivolumab Trough observed serum concentration (Ctrough) [ Time Frame: 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)] [ Time Frame: Up to two years ] To characterize the PK of lirilumab given in combination with nivolumab Clearance (CL) [ Time Frame: Up to two years ] To characteri

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026