Original Investigation

Dual Immune Checkpoint Inhibition Plus Neoadjuvant Chemoradiotherapy in Rectal Cancer

JAMA Network Open 10.1001/jamanetworkopen.2025.27769

August 22, 2025 at 11:00 AM EDT

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Is dual immune checkpoint inhibition (ICI) with ipilimumab and nivolumab safe and feasible in combination with neoadjuvant chemoradiotherapy (CRT) for rectal cancer?In this randomized clinical trial of 80 patients with rectal cancer, the differences between the CRT and the CRT plus ICI groups in the proportion of surgical complications (77% vs 77%, respectively) and reoperation rates (8% vs 7%, respectively) were not statistically significant.Integrating ipilimumab and nivolumab into neoadjuvant CRT is safe and feasible, warranting further translational analyses to identify the optimal timing and dosing of radiotherapy and ICIs.

Corresponding Author: Johannes Laengle, MD, PhD, Division of Visceral Surgery, Department of General Surgery, Comprehensive Cancer Center Vienna, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria (johannes.laengle@meduniwien.ac.at).

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