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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of death
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Incidence of death
Time Frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
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 AEs leading to discontinuation
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
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
Secondary Outcomes
- Maximum serum observed concentration (Cmax)(Up to two years)
- Incidence of dose-limiting toxicity (DLT)(Up to two years)
- Half-life (T-HALF)(Up to two years)
- Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)(Up to two years)
- Incidence of anti-drug antibody (ADA)(Up to two years)
- Volume of distribution at steady state (Vss)(Up to two years)
- Frequency of laboratory test toxicity grade shifting from baseline(Up to two years)
- Time of maximum observed serum concentration (Tmax)(Up to two years)
- Area under the serum concentration-time curve in one dosing interval [AUC(TAU)](Up to two years)
- Best overall response (BOR)(Up to two years)
- Duration of response (DOR)(Up to two years)
- Incidence of serious adverse events (SAEs)(Up to two years)
- Incidence of death(Up to two years)
- Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)](Up to two years)
- Trough observed serum concentration (Ctrough)(Up to two years)
- Incidence of adverse events (AEs)(Up to two years)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)](Up to two years)
- Clearance (CL)(Up to two years)
- Ratio of an exposure measure at steady-state to that after the first dose (AI)(Up to two years)
- Incidence of AEs leading to discontinuation(Up to two years)