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Completed
NCT04941768
An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
Conditions: Carcinoma, Renal Cell
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 105
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Location: Imelda Ziekenhuis Bonheiden
Summary
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.
Eligibility 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:
* 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
Source: ClinicalTrials.gov (NCT04941768). StuddyBuddy aggregates publicly available trial information.