Clinical trial NCT03203876: A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: Up to two years
measure: Incidence of adverse events (AEs)
timeFrame: Up to two years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to two years
measure: Incidence of death
timeFrame: Up to two years
measure: Frequency of laboratory test toxicity grade shifting from baseline
timeFrame: Up to two years
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to two years
Secondary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: Up to two years
measure: Incidence of adverse events (AEs)
timeFrame: Up to two years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to two years
measure: Incidence of death
timeFrame: Up to two years
measure: Frequency of laboratory test toxicity grade shifting from baseline
timeFrame: Up to two years
measure: Maximum serum observed concentration (Cmax)
timeFrame: Up to two years
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to two years
measure: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to two years
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to two years
measure: Trough observed serum concentration (Ctrough)
timeFrame: Up to two years
measure: Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
timeFrame: Up to two years
measure: Clearance (CL)
timeFrame: Up to two years
measure: Volume of distribution at steady state (Vss)
timeFrame: Up to two years
measure: Ratio of an exposure measure at steady-state to that after the first dose (AI)
timeFrame: Up to two years
measure: Half-life (T-HALF)
timeFrame: Up to two years
measure: Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
timeFrame: Up to two years
measure: Best overall response (BOR)
timeFrame: Up to two years
measure: Duration of response (DOR)
timeFrame: Up to two years
measure: Incidence of anti-drug antibody (ADA)
timeFrame: Up to two years
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to two years
measure: Maximum serum observed concentration (Cmax)
timeFrame: Up to two years
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to two years
measure: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to two years
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to two years
measure: Trough observed serum concentration (Ctrough)
timeFrame: Up to two years
measure: Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
timeFrame: Up to two years
measure: Clearance (CL)
timeFrame: Up to two years
measure: Volume of distribution at steady state (Vss)
timeFrame: Up to two years
measure: Ratio of an exposure measure at steady-state to that after the first dose (AI)
timeFrame: Up to two years
measure: Half-life (T-HALF)
timeFrame: Up to two years
measure: Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
timeFrame: Up to two years
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: