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Failed at data quality assurance process before any analyses would be performed
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The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inlyta | Drug | axitinib |
| |
| Bavencio | Drug | avelumab |
| |
| Keytruda | Drug | Pembrolizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe type of immune related adverse events and adverse events related to axitinib | describe type of immune related adverse events and adverse events related to axitinib | during treatment period |
| To describe the percentage of patients with documentation of dose modifications | describe dose modifications | during treatment period |
| To describe the percentage of patients with usage of concomitant high-dose corticosteroid | descriptive assessment | during treatment period |
| To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy | calculation of overall survival time | during study period |
| To estimate the best overall response (partial response, complete response, progressive disease, or stable disease | description of overall response | during treatment period |
| To estimate time to treatment discontinuation | calculation of duration of treatment | during treatment period |
| To estimate PFS | calculation of progression free survival | during treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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academic and community centers
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Inc. | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077784 | Axitinib |
| C000609138 | avelumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| 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 |
| 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 |