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

NCT05394493 | Completed

• 1 other identifier: B9991044
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Duration of Treatment (DoT)

  August 2019 through July 2023

Study Arms (1)

patients with advanced renal cell carcinoma

Drug: avelumab; Drug: axitinib

Interventions

avelumab DRUG

as provided in real world setting

patients with advanced renal cell carcinoma

axitinib DRUG

as provided in real world settings

patients with advanced renal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in between 10 and 15 National Health Service (NHS) hospital trusts and Health Boards

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Ltd

Sandwich, Kent, CT13 9NJ, United Kingdom

Location

Related Publications (1)

• Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.

  PMID: 36064785 DERIVED

Related Links

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

MeSH Terms

Interventions

avelumab; Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 27, 2022
• Study Start: June 11, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)