An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Carcinoma, Renal Cell
Age (in years)
18+
Participants needed
106
Est. Completion Date
May 9, 2025
Treatment type
Observational
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov identifier
NCT04941768
Study number
MS100070_0110
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