Background: In a phase 3 JAVELIN Renal 101randomized study, the combination of avelumab and axitinib demonstrated a significant improvement in progression-free survival (PFS; median 13.9 months) and objective response rate (ORR; 59.3%) among patients with metastatic clear-cell renal cell carcinoma (mRCC), leading to FDA approval as a first-line therapy. In our ambispective observational RAVE-Renal study, real-world data were gathered to assess the practical application and outcomes associated with the use of avelumab and axitinib in clinical settings. Methods: Patients were recruited from 13 sites, with data collected anonymously online. Key inclusion criteria were untreated mRCC and a minimum age of 18 years. Safety and efficacy assessments were conducted in all patients who received at least one dose of avelumab and axitinib. The primary endpoints included ORR and PFS, while secondary endpoints encompassed overall survival (OS) and the incidence of treatment-related adverse events (TRAEs). Results: At the time of data cutoff (February 03, 2024), a total of 125 patients were enrolled and treated. Median age was 61 years (range, 37-74). Patients were predominantly men (74.3%), previously nephrectomised (81.4%), had 2 and more metastatic sites (77.1%) including bone (24.3%), liver (15.7%), and brain (3%) metastases. IMDC risk was evaluated in 102 patients. Among these patients, 36 (35.3%) were categorized as having favorable risk, 50 (49%) as intermediate risk, and 16 (15.7%) as poor risk. The median number of avelumab infusions was 7 (range, 1-29). Table summarizes efficacy and safety data. Conclusions: The real-world study of first-line avelumab and axitinib therapy reveals comparable ORR and PFS to those observed in the pivotal clinical trial among patients with mRCC. The combination was well tolerated. Further follow-up of patients in the study is ongoing. Clinical trial information: KCRB01012022.

*Response was assessed in 122 patients (97.6%).