Clinical trial · Observational
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.
NCT05394493CI-TRIAL-00072006completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- label
- patients with advanced renal cell carcinoma
- interventionNames
- Drug: avelumab
- Drug: axitinib
Primary outcomes (5)
- measure
- Objective response (OR)
- timeFrame
- August 2019 through July 2023
- description
- "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. "
- measure
- Overall Survival (OS)
- timeFrame
- August 2019 through July 2023
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGed 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