Trial intelligence / Profile preview

Xevinapant with Chemoradiation in High-Risk HNSCC

NCT06084845Phase 2

Key facts

Status: Withdrawn
Start: Apr 2024
Primary completion: May 2028
Sponsor: ECOG-ACRIN Cancer Research Group
Modality: Small Molecules

Drugs: xevinapant
Conditions: head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 2, randomised, open-label trial of xevinapant in head and neck squamous cell carcinoma (HNSCC) (2 arms), sponsored by ECOG-ACRIN Cancer Research Group. Primary endpoint: Disease free survival at 2 years. Planned start Apr 2024; status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Arm A (chemoradiation)
Cisplatin/Carboplatin + Radiation
Arm B (chemoradiation, xevinapant)
Cisplatin/Carboplatin + Radiation + Xevinapant followed by Xevinapant maintenance

Who it enrols

Patients with stage III-IVB HPV-negative HNSCC (oral cavity, oropharynx, larynx, hypopharynx) who have undergone gross total resection with high-risk pathologic features (ENE and/or positive margins).

Endpoints

Primary

Disease free survival2 years

Secondary

Overall survival2 years
Incidence of adverse eventsUp to 30 days post treatment
Rates of distant metastasis
Local regional control

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