NCT06145412

A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer

A Phase II Trial of Xevinapant in Combination With Post-Operative Cisplatin and Radiotherapy for High Risk Head and Neck Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether treatment with Xevinapant added to standard chemoradiation after surgery is an effective treatment for people with high-risk head and neck cancers.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Xevinapan	Xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles)
DRUG	Cisplatin	Cisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks)
RADIATION	External beam	60 - 66 Gy in 2 Gy fractions for patients without gross disease and 70 Gy for patients with early recurrence) with concurrent cisplatin (40 mg/m2 once weekly)

Timeline

• Start date: 2023-11-16
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-11-24
• Last updated: 2025-08-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study