An Observational Chart Review Study To Describe The Real-World Outcomes And Use Of Avelumab In Combination With Axitinib For Treatment Of Patients With aRCC In The UK

Advanced Renal Cell Carcinoma Clinical Trial

Official title:

An Observational Chart Review Study to Describe the Real-world Outcomes and Use of Avelumab in Combination With Axitinib for Treatment of Patients With Advanced Renal Cell Carcinoma in the United Kingdom.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394493
• Other study ID #: B9991044
• Status: Completed
• Start date: June 11, 2021
• Est. completion date: August 30, 2023

Study information

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

Clinical Trial Summary

An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

• Patients with a documented diagnosis of aRCC.

• Patients aged =18 years old at the index event date.

• Patient initiated on treatment with avelumab in combination with axitinib ( =1 dose) on or after 1st August 2019.

Exclusion criteria

• Patients meeting any of the following criteria will not be included in the study:

• Patients who received avelumab in combination with axitinib as part of a clinical trial

• Patients initiated on avelumab in combination with axitinib less than 12 months from the end of data collection.

• Patients who are known to have opted out of participation in any research

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• avelumab
as provided in real world setting
• axitinib
as provided in real world settings

Locations

Country	Name	City	State
United Kingdom	Pfizer Ltd	Sandwich	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response (OR)	"Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).; CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.; "	August 2019 through July 2023
Primary	Overall Survival (OS)	Time in weeks or months from randomization (or the start of study treatment for non-randomized studies) to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization (or first dose of study medication for non-randomized studies) plus 1) divided by 7 or 30.44 if in months.	August 2019 through July 2023
Primary	Progression Free Survival (PFS)	Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7	August 2019 through July 2023
Primary	Duration of Response (DoR)	Median duration (50%) of tumor response for a subgroup of participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for DR. DR defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.	August 2019 through July 2023
Primary	Duration of Treatment (DoT)		August 2019 through July 2023

External Links

•   To obtain contact information for a study center near you, click here.