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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003200-39 | EudraCT Number | ||
| 18-214-15 | Other Identifier | Nektar Therapeutics |
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| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
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The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A (Part 1): Nivolumab + Axitinib | Experimental |
| |
| Part 1B (Part 1): Nivolumab + Cabozantinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) by severity (Part 1) | Up to 2.5 years | |
| Incidence of serious adverse events (SAEs) (Part 1) | Up to 2.5 years | |
| Incidence of dose-limiting toxicities (DLTs) (Part 1) | Up to 2.5 years | |
| Incidence of AEs leading to discontinuation (Part 1) | Up to 5 years | |
| Incidence of immune-mediated adverse events (imAEs) (Part 1) | Up to 5 years | |
| Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) | Up to 2.5 years | |
| Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) | Up to 2.5 years | |
| Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) | Up to 2.5 years |
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Inclusion Criteria:
Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Life Expectancy ≥ 12 weeks
Karnofsky Performance Status (KPS) of at least 70%
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
Males and females must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria 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 - 0005 | Springdale | Arkansas | 72762 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Axitinib | Drug | Specified dose on specified days |
|
|
| Cabozantinib | Drug | Specified dose on specified days |
|
|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Local Institution - 0001 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0009 | New York | New York | 10065 | United States |
| Local Institution | Portland | Oregon | 97213 | United States |
| Local Institution | Nashville | Tennessee | 37232 | United States |
| Local Institution - 0014 | Houston | Texas | 77030-3721 | United States |
| Local Institution - 0007 | Seattle | Washington | 98109 | United States |
| Local Institution - 0025 | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution - 0075 | Río Cuarto | Córdoba Province | X5800ALB | Argentina |
| Local Institution - 0026 | Buenos Aires | 1419 | Argentina |
| Local Institution - 0024 | San Juan | 5400 | Argentina |
| Local Institution - 0030 | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Local Institution - 0035 | Curitiba | Paraná | 80730-150 | Brazil |
| Local Institution - 0028 | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Local Institution - 0036 | Santa Cruz do Sul | Rio Grande do Sul | 96830-180 | Brazil |
| Local Institution - 0032 | Barretos | São Paulo | 14784400 | Brazil |
| Local Institution - 0029 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Local Institution - 0056 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0015 | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Local Institution - 0022 | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Local Institution - 0008 | Toronto | Ontario | M5G 1Z5 | Canada |
| Local Institution - 0079 | Marseille | 13273 | France |
| Local Institution - 0042 | Essen | 45147 | Germany |
| Local Institution - 0045 | Hanover | 30625 | Germany |
| Local Institution - 0040 | Jena | 07747 | Germany |
| Local Institution - 0044 | Munich | 81675 | Germany |
| Local Institution - 0041 | Nuremberg | 90419 | Germany |
| Local Institution - 0046 | Würzburg | 97080 | Germany |
| Local Institution - 0050 | Zapopan | Jalisco | 45070 | Mexico |
| Local Institution - 0048 | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution - 0049 | Monterrey | Nuevo León | 66460 | Mexico |
| Local Institution - 0055 | Querétaro | 76000 | Mexico |
| Local Institution - 0059 | Moscow | 115478 | Russia |
| Local Institution - 0052 | Moscow | 121205 | Russia |
| Local Institution - 0087 | Moscow | 121359 | Russia |
| Local Institution - 0051 | Novosibirsk | 630099 | Russia |
| Local Institution - 0085 | Omsk | 644013 | Russia |
| Local Institution - 0058 | Saint Petersburg | 197758 | Russia |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077784 | Axitinib |
| C558660 | cabozantinib |
| 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 |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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