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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part One Combination Therapy | Experimental | Lirilumab and Nivolumab |
|
| Part 2 Combination Therapy | Experimental | Lirilumab, Nivolumab and Ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lirilumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | To assess the safety and tolerability of lirilumab in combination with nivolumab | Up to two years |
| Incidence of adverse events (AEs) | To assess the safety and tolerability of lirilumab in combination with nivolumab | Up to two years |
| Incidence of serious adverse events (SAEs) | To assess the safety and tolerability of lirilumab in combination with nivolumab | Up to two years |
| Incidence of death | To assess the safety and tolerability of lirilumab in combination with nivolumab | 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 | Up to two years |
| Incidence of AEs leading to discontinuation | To assess the safety and tolerability of lirilumab in combination with nivolumab | Up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab | Up to two years |
| Incidence of adverse events (AEs) | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab |
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Inclusion Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kashiwa-shi | Chiba | 2778577 | Japan | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Ipilimumab | Biological | Specified dose on specified days |
|
|
| Up to two years |
| Incidence of serious adverse events (SAEs) | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab | Up to two years |
| Incidence of death | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab | 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 | Up to two years |
| Maximum serum observed concentration (Cmax) | To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab | Up to two years |
| Time of maximum observed serum concentration (Tmax) | To characterize the PK of lirilumab given in combination with nivolumab | 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 | 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 | Up to two years |
| Trough observed serum concentration (Ctrough) | To characterize the PK of lirilumab given in combination with nivolumab | 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 | Up to two years |
| Clearance (CL) | To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab | Up to two years |
| Volume of distribution at steady state (Vss) | To characterize the PK of lirilumab given in combination with nivolumab | 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 | Up to two years |
| Half-life (T-HALF) | To characterize the PK of lirilumab given in combination with nivolumab | 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 | Up to two years |
| Best overall response (BOR) | To assess the preliminary anti-tumor activity | Up to two years |
| Duration of response (DOR) | To assess the preliminary anti-tumor activity | Up to two years |
| Incidence of anti-drug antibody (ADA) | To characterize immunogenicity | Up to two years |
| Incidence of AEs leading to discontinuation | To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab | Up to two years |
| Maximum serum observed concentration (Cmax) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | Up to two years |
| Time of maximum observed serum concentration (Tmax) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | 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 | 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 | Up to two years |
| Trough observed serum concentration (Ctrough) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | 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 | Up to two years |
| Clearance (CL) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | Up to two years |
| Volume of distribution at steady state (Vss) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | 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 | Up to two years |
| Half-life (T-HALF) | To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab | 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 | Up to two years |
| Kobe |
| Hyōgo |
| 6500017 |
| Japan |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000723331 | lirilumab |
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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