Clinical trial · Observational
An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
Real-world Evaluation of Efficacy and Safety With Avelumab (BAVENCIO®) + Axitinib (INLYTA®) in Patients With aRCC in Multiple EU Countries (AVION)
NCT04941768CI-TRIAL-00114930completedResults postedClinicalTrials.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)
The main purpose of this study is to expand knowledge on the effectiveness of Avelumab intravenous infusion in combination with Axitinib as the first-line therapy in participants with advanced renal-cell carcinoma (aRCC) in addition to the safety and tolerability under routine conditions of daily clinical practice.
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 |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Avelumab + Axitinib
- description
- There will not be any study-specific interventions in this study. Participants with advanced RCC receiving 800 milligrams (mg) of Avelumab intravenously every 2 weeks in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice will be observed for 24 months in this study.
Primary outcomes (1)
- measure
- Overall Survival Rate
- timeFrame
- At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
- description
- Overall survival rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
Secondary outcomes (19)
- measure
- Overall Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Participants with a histologically confirmed diagnosis of RCC with any histological origin * Participants with a locally advanced/metastatic disease (that is \[ie\], newly diagnosed Stage 4 RCC per American Joint Committee on Cancer) or has recurrent disease * Participants has received 1 or 2 cycles of Avelumab plus Axitinib treatment as a first-line therapy according to the approved Summary of Product Characteristics (SmPC) * Participants willing to sign the written informed consent form (ICF) to participate in this study Exclusion Criteria: * Participants with contraindications for Avelumab or Axitinib according to the approved SmPC * Participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib
References
Publications (0)
Data not yet available
No reference posted for this study.