NCT05724602

Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Radiotherapy Plus Xevinapant or Placebo in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma: a Randomized Phase II Study RAVINA

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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: * Arm A: 3 cycles of xevinapant (200 mg/day from Day 1 to 14, per cycle) + intensive modulated radiotherapy (IMRT) followed by 3 cycles of xevinapant in monotherapy phase (200 mg/day from Day 1 to 14, per cycle) * Arm B: 3 cycles of placebo (from Day 1 to 14, per cycle) + IMRT followed by 3 cycles of placebo in monotherapy phase (from Day 1 to 14, per cycle). 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.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Xevinapant	3 cycles of xevinapant + IMRT followed by 3 cycles of xevinapant as monotherapy
DRUG	Placebo	3 cycles of placebo + IMRT followed by 3 cycles of placebo as monotherapy

Timeline

• Start date: 2023-11-15
• Primary completion: 2029-07-01
• Completion: 2029-10-01
• First posted: 2023-02-13
• Last updated: 2024-08-27

Locations

26 sites across 10 countries: Belgium, France, Germany, Ireland, Italy, Netherlands, Norway, Slovenia, Spain, United Kingdom