Renal Cell Carcinoma
Conditions
Brief summary
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
Detailed description
not mandatory
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point * Age 18 years or older at the time of aRCC diagnosis * Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe type of immune related adverse events and adverse events related to axitinib | during treatment period | describe type of immune related adverse events and adverse events related to axitinib |
| To describe the percentage of patients with documentation of dose modifications | during treatment period | describe dose modifications |
| To describe the percentage of patients with usage of concomitant high-dose corticosteroid | during treatment period | descriptive assessment |
| 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 | during study period | calculation of overall survival time |
| To estimate the best overall response (partial response, complete response, progressive disease, or stable disease | during treatment period | description of overall response |
| To estimate time to treatment discontinuation | during treatment period | calculation of duration of treatment |
| To estimate PFS | during treatment period | calculation of progression free survival |
Countries
United States
Outcome results
None listed