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Clinical Trial
. 2025 Jun;131(7):1293-1301.
doi: 10.1002/jso.28070. Epub 2025 Jan 5.

Phase I/II Trial of Perioperative Avelumab in Combination With Chemoradiation in the Treatment of Stage II/III Resectable Esophageal and Gastroesophageal Junction Cancer

Nataliya V Uboha  1   2 , Mustafa M Basree  3 , Jens C Eickhoff  4 , Dustin A Deming  1   2 , Kristina Matkowskyj  5   6 , James Maloney  5   7 , Daniel McCarthy  7 , Malcolm DeCamp  7 , Noelle LoConte  1   2 , Philip B Emmerich  1 , Sean Kraus  1 , Monica A Patel  1   2 , Jeremy D Kratz  1   2   5   8 , Sam J Lubner  1   2 , Newton Hurst  3 , Michael F Bassetti  3
Affiliations
Clinical Trial

Phase I/II Trial of Perioperative Avelumab in Combination With Chemoradiation in the Treatment of Stage II/III Resectable Esophageal and Gastroesophageal Junction Cancer

Nataliya V Uboha et al. J Surg Oncol. 2025 Jun.

Abstract

Background and objectives: Standard treatment of patients with stage II/III esophageal or gastroesophageal junction (E/GEJ) cancer involves neoadjuvant chemoradiation (nCRT), resection, and immunotherapy. Our trial evaluated the addition of perioperative avelumab to standard treatments.

Methods: Patients with resectable E/GEJ cancers received avelumab with nCRT and adjuvant avelumab after resection. Primary endpoints for phase I and II portions were safety and pathologic complete response (pCR) rate, respectively. Secondary endpoints included recurrence-free survival (RFS), surgical complication prevalence, and R0 resection rate.

Results: Twenty-two patients enrolled in the study. Median follow-up during data cutoff was 23.9 months. There were no dose-limiting toxicities during the run-in phase. Nineteen patients (86.4%) underwent resection with R0 resection rate of 78.9% and with pCR rate of 26%. Most common treatment-related adverse events (TRAE) were cytopenias from chemoradiation. Aside from one grade ≥ 3 avelumab-related hypersensitivity, no grade ≥ 3 avelumab TRAEs were seen. Median RFS was not reached, and 1-year RFS and overall survival were 71% and 81%, respectively. The study was terminated before full planned accrual due to standard practice change based on the CheckMate 577 trial.

Conclusions: The addition of perioperative avelumab to nCRT was tolerable and demonstrated promising outcomes.

Keywords: chemoradiation; esophageal cancer; gastroesophageal adenocarcinoma; immunotherapy.

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Figures

Figure 1
Figure 1
Kaplan‐Meier curve of recurrence‐free survival (solid line) with 95% confidence interval boundaries.
See this image and copyright information in PMC

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