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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04555603
Other study ID # A4061096
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date February 22, 2021

Study information

Verified date November 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI


Description:

not mandatory


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 22, 2021
Est. primary completion date February 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Inlyta
axitinib
Bavencio
avelumab
Keytruda
Pembrolizumab

Locations

Country Name City State
United States Pfizer Inc. New York New York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary To describe the percentage of patients with documentation of dose modifications describe dose modifications during treatment period
Primary To describe the percentage of patients with usage of concomitant high-dose corticosteroid descriptive assessment during treatment period
Primary 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
Primary To estimate the best overall response (partial response, complete response, progressive disease, or stable disease description of overall response during treatment period
Primary To estimate time to treatment discontinuation calculation of duration of treatment during treatment period
Primary To estimate PFS calculation of progression free survival during treatment period
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