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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04941768). StuddyBuddy aggregates publicly available trial information.