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An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)

NCT04941768

CompletedN/A

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions: Carcinoma, Renal Cell

Countries: Belgium, Germany, Greece, Russia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (61)

Bonheiden, Belgium
Brasschaat, Belgium
Bruges, Belgium
Amberg, Germany
Aschaffenburg, Germany
Berlin, Germany
Biberach an der Riss, Germany
Bielefeld, Germany
Bielefeld, Germany
Braunschweig, Germany
Deggendorf, Germany
Dresden, Germany
Eisenach, Germany
Erlangen, Germany
Essen, Germany
Friedrichshafen, Germany
Fürth, Germany
Fürth, Germany
Goslar, Germany
Halberstadt, Germany
Hamburg, Germany
Hanover, Germany
Hanover, Germany
Heinsberg, Germany
Jena, Germany
L.-Eisleben, Germany
Luckenwalde, Germany
Lübeck, Germany
Magdeburg, Germany
Minden, Germany
+ 31 more on CT.gov