On December 14, 2023 The European Organisation for Research and Treatment of Cancer (EORTC) reported the launch of EORTC 2120 RAVINA trial supported by the EORTC Head and Neck Cancer Group and by Merck entitled "Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study" (Press release, EORTC, DEC 14, 2023, View Source [SID1234638563]).

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This randomised, placebo-controlled, phase II study will determine the efficacy and safety of xevinapant with radiotherapy in older patients. Patients aged 70 years or older with LA-HNSCC of oral cavity, oropharynx, hypopharynx, or larynx for which treatment with radiotherapy only is recommended will be enrolled in the study.

This study aims to find out whether the addition of xevinapant increases response to radiotherapy, progression free survival and overall survival and may impact health-related quality of life, frailty and circulating markers.

Launch of the trial across Europe

Ten countries have been selected to participate in the trial (Italy, France, Belgium, Spain, Ireland, Germany, the Netherlands, Slovenia, Norway and the United Kingdom) with 27 sites expected to enrol approximately 230 patients.

Merck will provide xevinapant and the placebo. The study was submitted under the new EU Clinical Trial Regulation in March 2023. Today, 7 sites have been authorised in five countries. First Patient In has been enrolled in Belgium.

Xevinapant (formerly known as Debio 1143) is an investigational, orally taken Inhibitor of Apoptosis Protein (IAP) inhibitor that may promote cancer cell death via apoptosis. Xevinapant is believed to sensitize tumour cells for various cytotoxic therapies, including radiotherapy and chemotherapy.

Improving progression-free survival with limited toxicity in older patients

"Locally advanced head and neck cancer is a debilitating disease that is increasingly diagnosed in older patients. These patients often do not tolerate or benefit from addition of chemotherapy to radiotherapy and are therefore treated with radiotherapy alone. The disease relapses in more than half of the patients. An earlier study showed that xevinapant added to chemoradiotherapy reduced relapses and improved overall survival with limited extra toxicity. We therefore hypothesize that xevinapant will also improve efficacy of radiotherapy alone" said Dr. Sjoukje Oosting, Medical Oncologist at the University Medical Centre in Groningen, the Netherlands, lead investigator of the EORTC 2120 RAVINA study.