Table of Contents
- Trial overview
- Who was studied
- How the trials were designed
- Main endpoints
- What the trials aimed to show
- Completed studies
Trial overview
Clinical trials are studying Xevinapant in people with squamous cell carcinoma of the head and neck, which is a cancer that starts in the lining cells of the mouth, throat, voice box, or nearby areas.[1][2][3]
These studies look at Xevinapant given with radiotherapy, and in one trial with cetuximab plus radiotherapy, to see whether outcomes are better than with placebo.[1][2][3]
Who was studied
The trials included different patient groups with head and neck cancer.[1][2][3]
Resected disease: one study enrolled people whose cancer had been removed by surgery and who were at high risk.[1]
Locally advanced disease: two studies focused on cancer that had grown beyond an early stage, but was still being treated in the head and neck area.[2][3]
Older patients: one Phase 2 study specifically studied older people with locally advanced head and neck cancer.[2]
Cisplatin-ineligible participants: one Phase 3 study included people who could not receive cisplatin, a common cancer treatment, based on the trial title.[1]
How the trials were designed
All three studies were interventional, which means the researchers assigned study treatments to compare outcomes.[1][2][3]
Two trials were Phase 3 studies, and one was a Phase 2 study.[1][2][3]
Phase 2 studies usually look for early signs that a treatment may help, while Phase 3 studies compare treatments in larger groups of people.[2][1][3]
One Phase 3 study compared Xevinapant plus radiotherapy with placebo plus radiotherapy after surgery in high-risk people who could not receive cisplatin.[1]
One Phase 2 study compared Xevinapant plus radiotherapy with placebo plus radiotherapy in older patients.[2]
One Phase 3 study compared Xevinapant plus cetuximab plus radiotherapy with placebo plus cetuximab plus radiotherapy.[3]
Main endpoints
The trials were built around survival and cancer-control outcomes.[1][2][3]
Disease-free survival (DFS) was the main outcome in the Phase 3 post-surgery study.[1]
Locoregional event-free survival (LREFS) was the main outcome in the Phase 2 older-patient study. This means the study tracked how long people stayed free from cancer return or worsening in the same area or nearby area, new head and neck cancer in the radiation field, or death from any cause.[2]
Progression-free survival (PFS) was the main outcome in the Phase 3 cetuximab study. This measures the time until the cancer gets worse, treatment fails before a complete response, or the cancer comes back after a complete response, or death occurs.[3]
What the trials aimed to show
The main purpose of the Phase 3 post-surgery study was to show better disease-free survival when Xevinapant was added to radiotherapy, compared with placebo plus radiotherapy, regardless of later cancer treatment.[1]
The Phase 2 study aimed to find out whether adding Xevinapant to radiotherapy could improve locoregional event-free survival in older patients with locally advanced head and neck cancer.[2]
The Phase 3 cetuximab study aimed to show better progression-free survival with Xevinapant-cetuximab-radiotherapy compared with placebo-cetuximab-radiotherapy.[3]
Completed studies
All three trials in the source data are listed as completed, which means the planned study work has ended.[1][2][3]
The completed studies include a large Phase 3 trial with 648 participants, a Phase 2 trial with 244 participants, and another Phase 3 trial with 377 participants.[1][2][3]
