Xevinapant
Sponsors
European Organisation For Research And Treatment Of Cancer, Groupe Oncologie Radiotherapie Tete Cou, Merck Healthcare KGaA, EMD Serono Research & Development Institute, Inc., European Organisation for Research and Treatment of Cancer - EORTC
Conditions
Head and Neck CancerHead and Neck NeoplasmsHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaLocally Advanced Head and Neck Squamous Cell CarcinomaLocally advanced squamous cell carcinoma of the head and neckOral Cavity Squamous Cell Carcinoma
Phase 1
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
TerminatedNCT06056310
Start: 2024-01-18End: 2024-08-20Updated: 2025-09-29
Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer
TerminatedNCT06110195
Start: 2024-01-24End: 2025-05-12Updated: 2026-03-31
Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)
WithdrawnNCT06463184
Start: 2024-07-22End: 2027-06-30Updated: 2024-12-04
Phase 2
Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
SuspendedNCT05724602
Start: 2023-11-15End: 2029-10-31Target: 230Updated: 2024-08-27
EORTC 2120-HNCG: Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study (Ravina)
CompletedCTIS2022-502339-20-00
Start: 2023-11-15End: 2025-06-11Target: 225Updated: 2023-12-21
Testing the Addition of an Investigational Drug, Xevinapant, to Usual Radiation Therapy Plus Cisplatin/Carboplatin for Patients With Head and Neck Cancer
WithdrawnNCT06084845
Start: 2024-04-12End: 2028-05-31Updated: 2024-07-25
Phase 3
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
TerminatedNCT05386550
Start: 2022-10-06End: 2024-08-27Updated: 2026-02-19
Study Comparing RT With Cetuximab + Xevinapant to RT With Cetuximab-placebo in Patients With Head and Neck Cancer
TerminatedNCT05930938
Start: 2023-12-12End: 2024-09-30Updated: 2025-05-09
A double-blind randomized, Phase III study of radiotherapy combined with cetuXimab + Xevinapant compared to radiotherapy combined with cetuximab (Standard of care) + placebo in patients with Locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN), unfit for high-dose cisplatin (XXL study)
CompletedCTIS2022-502584-38-00
Start: 2023-12-12End: 2024-09-30Target: 377Updated: 2024-02-14
A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin
CompletedCTIS2023-508528-36-00
Start: 2022-12-16End: 2024-08-27Target: 262Updated: 2024-09-16