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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Carcinoma, Renal Cell

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04941768

MS100070_0110

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

105 participants in 1 patient group

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.