Trial in Development Feature: NRG-HN012

April 10 2024

NRG-HN012 (The “XCELSIOR” Study): Randomized Phase II/III Trial of Radiotherapy with Concurrent Xevinapant vs. Cetuximab for Locoregionally Advanced Head and Neck Cancer Patients with a Cisplatin Contraindication

The phase II/III NRG-HN012 study, also known as the “XCELSIOR” study is currently in development in the NRG Oncology head and neck cancer portfolio. When activated, this trial is expected to accrue patients with locoregionally advanced head and neck squamous cell carcinoma who have a contraindication to cisplatin treatment. Patients would be stratified then randomly assigned to receive either radiotherapy with cetuximab (standard treatment) or radiotherapy with xevinapant. The phase II portion of this study will aim to determine whether there is a signal that the radiotherapy and xevinapant improves investigator-assessed progression-free survival when compared to the standard treatment for this patient population. In phase III, this study is designed to determine whether the experimental radiotherapy and xevinapant treatment will improve overall survival for these patients when compared to the standard treatment.

“The current standard of care for patients with head and neck squamous cell carcinoma is treatment with concurrent radiotherapy and cisplatin chemotherapy. However, one-third of patients with this disease type have a contraindication to cisplatin due to advanced age or comorbidities. It is important that we find a best alternative treatment for this population outside of cisplatin-based treatments that help improve their survival outcomes,” stated Loren K. Mell, MD, at the University of California, San Diego, and the Principal Investigator of the XCELSIOR trial.

More information will be circulated when this trial activates.

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