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The purpose of this study is to learn about the effectiveness of the first and later lines of medicines on clinical outcomes in people with mRCC.
The study includes participants who:
This is a study that looks into the data collected through a particular database from selected academic clinical sites participating in this study. The data of interest include:
We will compare the experiences of people receiving different combinations of treatments and see if there are any differences in the effectiveness of these medicines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mRCC | Patients with mRCC in the IMDC |
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| Measure | Description | Time Frame |
|---|---|---|
| Demographical characteristics | Gender Age at time of 1L initiation Race Region indicator (i.e., US vs. ex-US) | From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months) |
| Date of mRCC diagnosis | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | |
| Prior nephrectomy status | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | |
| Date of nephrectomy (if applicable) | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | |
| Tumor characteristics | Histology type (i.e., clear cell vs. non-clear cell RCC) Number of metastatic sites (e.g., 1 site or more than 1 site) Site of metastases (e.g., brain, bone, lung) | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| IMDC risk score | Assessed on index date and at initiation of each LOT | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Number of lines of therapy received by each patient | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | |
| Treatment agents received at each line of therapy | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
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Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria for this study
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This is a retrospective, longitudinal cohort study that involves the analysis of data collected through the IMDC database from selected academic clinical sites participating in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Headquarters | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2022 | May 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Duration of each line of therapy | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Time from discontinuation of previous line of therapy to initiation of subsequent line of therapy | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Reason for discontinuation for each line of therapy | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Time to treatment discontinuation (TTD) | Defined as the time from treatment initiation to discontinuation of each therapy due to any reason including progression, death, or toxicity | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Time to next treatment (TTNT) | Defined as time from the initiation of 1L treatment to initiation of subsequent therapy or death | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Physician-assessed best response | Overall best response rate (complete or partial) Stable disease Progressive disease | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| Overall survival | Defined as the time between initiation of 1L IO combination therapy to death | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) |
| D009369 | 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 |