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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203876
• Other study ID #: CA223-030
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2017
• Est. completion date: August 6, 2020

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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/exclusion criteria could apply

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Biological:
• Lirilumab
Specified dose on specified days
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Kobe-shi	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT)	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Primary	Incidence of adverse events (AEs)	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Primary	Incidence of serious adverse events (SAEs)	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Primary	Incidence of death	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Primary	Frequency of laboratory test toxicity grade shifting from baseline	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Primary	Incidence of AEs leading to discontinuation	To assess the safety and tolerability of lirilumab in combination with nivolumab	Up to two years
Secondary	Incidence of dose-limiting toxicity (DLT)	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Incidence of adverse events (AEs)	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Incidence of serious adverse events (SAEs)	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Incidence of death	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Frequency of laboratory test toxicity grade shifting from baseline	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Maximum serum observed concentration (Cmax)	To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab	Up to two years
Secondary	Time of maximum observed serum concentration (Tmax)	To characterize the PK of lirilumab given in combination with nivolumab	Up to two years
Secondary	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	Up to two years
Secondary	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	Up to two years
Secondary	Trough observed serum concentration (Ctrough)	To characterize the PK of lirilumab given in combination with nivolumab	Up to two years
Secondary	Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]	To characterize the PK of lirilumab given in combination with nivolumab	Up to two years
Secondary	Clearance (CL)	To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab	Up to two years
Secondary	Volume of distribution at steady state (Vss)	To characterize the PK of lirilumab given in combination with nivolumab	Up to two years
Secondary	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	Up to two years
Secondary	Half-life (T-HALF)	To characterize the PK of lirilumab given in combination with nivolumab	Up to two years
Secondary	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	Up to two years
Secondary	Best overall response (BOR)	To assess the preliminary anti-tumor activity	Up to two years
Secondary	Duration of response (DOR)	To assess the preliminary anti-tumor activity	Up to two years
Secondary	Incidence of anti-drug antibody (ADA)	To characterize immunogenicity	Up to two years
Secondary	Incidence of AEs leading to discontinuation	To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab	Up to two years
Secondary	Maximum serum observed concentration (Cmax)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	Time of maximum observed serum concentration (Tmax)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	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	Up to two years
Secondary	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	Up to two years
Secondary	Trough observed serum concentration (Ctrough)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	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	Up to two years
Secondary	Clearance (CL)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	Volume of distribution at steady state (Vss)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	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	Up to two years
Secondary	Half-life (T-HALF)	To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab	Up to two years
Secondary	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	Up to two years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls