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| ID | Type | Description | Link |
|---|---|---|---|
| 18-214-14 | Other Identifier | Nektar Therapeutics |
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| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | NKTR-214 + nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-214 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Approximately 2 years | |
| Incidence of serious adverse events (SAEs) | Approximately 2 years | |
| Incidence of AEs leading to discontinuation | Approximately 2 years | |
| Incidence of deaths | Approximately 2 years | |
| Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria | Approximately 2 years | |
| Incidence of laboratory abnormalities | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Approximately 2 years | |
| Time of maximum observed concentration (Tmax) | Approximately 2 years | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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 | Chuo-ku | Tokyo | 1040045 | Japan |
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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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Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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| ID | Term |
|---|---|
| C000611752 | bempegaldesleukin |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Approximately 2 years |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Approximately 2 years |
| Total body clearance (CLT) | Approximately 2 years |
| Volume of distribution (Vz) | Approximately 2 years |
| Apparent terminal phase half-life (T-HALF) | Approximately 2 years |
| Trough observed serum concentration at the end of the dosing interval (Ctrough) | Approximately 2 years |
| Incidence of anti-drug antibodies (ADA) to NKTR-214 | Approximately 2 years |
| Incidence of anti-drug antibodies (ADA) to nivolumab | Approximately 2 years |
| Best overall response (BOR) | Approximately 2 years |
| Duration of response (DOR) | Approximately 2 years |
| FDA Safety Alerts and Recalls | View source |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |