Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urelumab (+ Nivolumab) intravenous (IV) infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urelumab | Drug |
| ||
| Nivolumab |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up | |
| Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up | |
| Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up | |
| Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 100 days of follow-up | |
| Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kobe | Hyōgo | 6500017 | Japan |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000620833 | urelumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From day 1 of treatment up to 100 days of follow-up |
| Cmax (Maximum observed serum concentration) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| Ctrough (Trough observed serum concentration) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| Tmax (Time of maximum observed serum concentration) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| T-HALF (Elimination half life) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| CLT (Total body clearance) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| Vss (Volume of distribution at steady state) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up |
| Cmax of urelumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| Coeff of urelumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| Ctrough of urelumab and nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| Tmax of urelumab and nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| AUC(0-T) of urelumab and nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| AUC(TAU) of urelumab and nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| AUC(INF) of urelumab and nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| T-HALF of urelumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| CLT of urelumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| Vss of urelumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up |
| Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone | 21 days/cycle for Urelumab monotherapy | Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up |
| ADA status of the subject in response to Urelumab and Nivolumab when co-administered | 28 days/cycle for combination therapy of Urelumab and Nivolumab | Cycle 1, 2, 4, 5, 9, up to 100 days of follow up |
| Best overall response (BOR) of urelumab monotherapy | Every 6-8 weeks during the treatment period |
| BOR of urelumab and nivolumab combination therapy | Every 6-8 weeks during the treatment period |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |