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
- Registration Number
- NCT05394493
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with advanced renal cell carcinoma avelumab - patients with advanced renal cell carcinoma axitinib -
- Primary Outcome Measures
Name Time Method Objective response (OR) August 2019 through July 2023 "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.
"Overall Survival (OS) August 2019 through July 2023 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.
Progression Free Survival (PFS) August 2019 through July 2023 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
Duration of Response (DoR) August 2019 through July 2023 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.
Duration of Treatment (DoT) August 2019 through July 2023
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Ltd
🇬🇧Sandwich, Kent, United Kingdom