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

Completed

• Conditions: Carcinoma, Renal Cell

• Registration Number: NCT04941768
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-28
• Study Start: 2021-08-09
• Primary Completion: 2024-08-08
• Study Completion: 2025-04-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) Rate at Month 12	Time from first dose of study drug up to Month 12

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) Rate at Month 24	Time from first dose of study drug up to Month 24
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Time from first dose of study drug up to Month 24
Progression-free Survival 2 (PFS2) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator	Time from first dose of study drug to the date of disease progression on second-line treatment or death from any cause, assessed up to Month 24
Health-related Quality Of Life (HRQoL) According to National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCNFACTFKSI-19)	Baseline, Month 24
Duration of Avelumab plus Axitinib Therapy Among Participants Who Discontinued the Study Drugs Due to All-Cause Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3	Time from first dose of study drug up to Month 24
Overall Survival (OS)	Time from first dose of study drug to the date of death from any cause, assessed up to Month 24
Overall Response (OR) Rate Assessed by Investigator at Month 24	Time from first dose of study drug up to Month 24
Disease Control Rate (DCR) Assessed by Investigator at Month 24	Time from first dose of study drug up to Month 24
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator	Time from first dose of study drug to the date of disease progression or death from any cause, assessed up to Month 24
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs, AEs Leading to Permanent Treatment Discontinuation and AEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)	Time from first dose of study drug up to Month 24
Number of Participants with Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0	Time from first dose of study drug up to Month 24
Percentage of Participants with Therapy Modifications Due to Adverse Event Related to Avelumab plus Axitinib Therapy	Time from first dose of study drug up to Month 24
Number of Participants with Different Types of Medical Intervention or Medications Used for the Management of Adverse Events (AEs) Related to Avelumab plus Axitinib Therapy	Time from first dose of study drug up to Month 24
Number of Participants with Greater Than of Equal to (>=) Grade-3 Adverse Events (AEs) Leading to Discontinuation According to Medical Dictionary for Regulatory Activities (MedDRA)	Time from first dose of study drug up to Month 24
Time to Onset of All-cause Adverse Events (AEs)	Time from first dose of study drug up to Month 24
Duration of All-cause Adverse Events (AEs)	Time from first dose of study drug up to Month 24
Number of Participants with All-cause Adverse Events (AEs) Outcomes (Resolved, Resolving, not Resolved, Resolved with Sequelae, Fatal, Unknown)	Time from first dose of study drug up to Month 24
Time to Second-line Therapy Initiation	Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24
Percentage of Participants Receiving Later-line therapy	Time from first dose of study drug up to Month 24
Number of Participants with Patient-reported Potential Signs and Symptoms of Immune-related Adverse Events (AEs)	Time from first dose of study drug up to Month 24

Trial Locations

Locations (61)

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

AZ KLINA; 🇧🇪 Brasschaat, Belgium

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

Klinikum St. Marien Amberg; 🇩🇪 Amberg, Germany

Klinikum Aschaffenburg Medizinische Klinik; 🇩🇪 Aschaffenburg, Germany

Zentrum für urologische Onkologie; 🇩🇪 Berlin, Germany

Biberach; 🇩🇪 Biberach an der Riss, Germany

Evangelisches Klinikum Bethel; 🇩🇪 Bielefeld, Germany

Evangelisches Krankenhaus Bielefeld; 🇩🇪 Bielefeld, Germany

Urologie im Schlosscarree; 🇩🇪 Braunschweig, Germany

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