Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Pfizer
- Locations
- 1
- Primary Endpoint
- To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
Time Frame: during treatment period
description of overall response
To estimate time to treatment discontinuation
Time Frame: during treatment period
calculation of duration of treatment
To describe the percentage of patients with documentation of dose modifications
Time Frame: during treatment period
describe dose modifications
To describe the percentage of patients with usage of concomitant high-dose corticosteroid
Time Frame: 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
Time Frame: during study period
calculation of overall survival time
To estimate PFS
Time Frame: during treatment period
calculation of progression free survival
To describe type of immune related adverse events and adverse events related to axitinib
Time Frame: during treatment period
describe type of immune related adverse events and adverse events related to axitinib
Secondary Outcomes
No secondary outcomes reported