Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Complement C3

Complement C3d

Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.

Xevinapant

Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).

Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week

intensity-modulated radiation therapy (IMRT)

US Medical Information

Communication Center

Ragisha Gopalakrishnan

Ammar W Sukari

Rafi Kabarriti

Jessica Geiger

Ryan A Vaca

Marika Rasschaert

Michael Saerens

Frederic Forget

Willem Lybaert

Aron Popovtzer

Young Jin Choi

Keun-Wook Lee

Ji-Hyun Park

Hye Ryun Kim

Jung Hoon Kim

Jordi Rubio

Javier Serrano Andreu

Jaime Rubio Perez

Maria Jose Flor Oncala

Hui-Ching Wang

Ching-Yun Hsieh

Huai Cheng Huang

Muh-Hwa Yang

Medical Responsible

The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)	NCT06056310	Head and Neck C...	Xevinapant Cisplatin intensity-modul...	18 Years -	EMD Serono
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)	NCT06056310	Head and Neck C...	Xevinapant Cisplatin intensity-modul...	18 Years -	EMD Serono

Spots Global Cancer Trial Database for combination with crt