N/A
Completed N=105
An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT04941768 ↗
Enrolled (actual)
105
Serious AEs
36.5%
Results posted
Nov 2025
Primary outcomePrimary: Overall Survival (OS) Rate — 82.7 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) Rate |
82.7 | — |
| SECONDARY OS Rate |
— | — |
| SECONDARY Duration of OS |
— | — |
| SECONDARY Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date |
— | — |
| SECONDARY Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date |
— | — |
| SECONDARY Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
— | — |
| SECONDARY Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator |
11.3 | — |
| SECONDARY Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator |
NA | — |
| SECONDARY Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score |
58.3; -0.2; -1.1; -0.6; -0.3; -1.4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA) |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3 |
— | — |
| SECONDARY Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Study Drugs Due to All-Cause AEs >= Grade 3 |
— | — |
| SECONDARY Time to Onset of All-cause AEs |
— | — |
| SECONDARY Duration of All-cause AEs |
— | — |
| SECONDARY Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy |
— | — |
| SECONDARY Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy |
47; 6; 11 | — |
| SECONDARY Percentage of Participants Receiving Later-line Therapy |
— | — |
| SECONDARY Time to Second-line Therapy Initiation |
0.3 | — |
| SECONDARY Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04941768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.