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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05394493
Collaborator
(none)
120
1
30.6
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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.
Actual Study Start Date :
Jun 11, 2021
Anticipated Primary Completion Date :
Dec 29, 2023
Anticipated Study Completion Date :
Dec 29, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with advanced renal cell carcinoma

Drug: avelumab
as provided in real world setting

Drug: axitinib
as provided in real world settings

Outcome Measures

Primary Outcome Measures

  1. 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. "

  2. 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.

  3. 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

  4. 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.

  5. Duration of Treatment (DoT) [August 2019 through July 2023]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Ltd Sandwich Kent United Kingdom CT13 9NJ

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05394493
Other Study ID Numbers:
  • B9991044
First Posted:
May 27, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022