A Phase 2 interventional study of Xevinapant and Placebo in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 26 sites in 10 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx.
Upon confirmation of eligibility, subjects will be enrolled and randomized in a 1:1 ratio to:
Patients will be stratified by institution, disease location/p16 status (p16 positive oropharyngeal cancer, versus others), G8 score. Three strata for the G8 will be used (>14, versus 11-14 versus \<11).
Patients will undergo imaging in week 20 and upon clinical suspicion of progression/recurrence. Clinical examination will take place every 12 weeks in the first 3 years.
European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
3 cycles of xevinapant (200 mg/day from Day 1 to 14, per 21-day cycle) + IMRT followed by 3 cycles of xevinapant in monotherapy (200 mg/day from Day 1 to 14, per 21-day cycle)
Drug: Xevinapant
3 cycles of placebo (from Day 1 to 14, per 21-day cycle) + IMRT followed by 3 cycles of placebo in monotherapy (from Day 1 to 14, per 21-day cycle).
Drug: Placebo
3 cycles of xevinapant + IMRT followed by 3 cycles of xevinapant as monotherapy
3 cycles of placebo + IMRT followed by 3 cycles of placebo as monotherapy
Locoregional event-free survival (LREFS)
To demonstrate superior efficacy in terms of locoregional event-free survival of xevinapant vs placebo when added to radical radiotherapy in older patients with LA-HNSCC.
Time frame: 5 years after first patient in
Response to treatment by RECIST 1.1
To estimate the added value of xevinapant over RT alone in terms of response to treatment.
Time frame: 5 years after first patient in
Progression Free Survival as assessed by the local investigator
To estimate the added value of xevinapant over RT alone in PFS.
Time frame: 5 years after first patient in
Overall Survival
To estimate the added value of xevinapant over RT alone in OS.
Time frame: 5 years after first patient in
Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting
To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms.
Time frame: 5 years after first patient in
HRQOL as assessed by global health/QoL and physical functioning scales at week 20 (Fatigue scale from the Quality of Life Core-30 (QLQ-C30) and pain in the head and neck scale from Item List-225 (IL225)).
To assess non-inferiority of xevinapant arm compared to placebo in terms of health-related quality of life (HRQoL) as assessed by the EORTC QLQ-C30 global health/QoL and physical functioning scales. The questionnaires employ 50 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall HRQoL. For functional and global HRQoL scales, higher scores represent a better level of functioning and are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represents more severe symptoms.
Time frame: 5 years after first patient in
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC