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Completed

NCT Number: NCT05394493

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

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.

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Key information

Conditions

Advanced Renal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Ltd

Sandwich, Kent, CT13 9NJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avelumab

Drug

as provided in real world setting

Axitinib

Drug

as provided in real world settings

Primary outcomes

  1. Objective response (OR)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: August 2019 through July 2023

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 27, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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