Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Cisplatin

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Xevinapant (Debio 1143)

Monotherapy period (Cycles 4-6):

• Xevinapant (Debio 1143)

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Matched placebo

Monotherapy period (Cycles 4-6):

• Matched placebo

Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

Xevinapant (Debio 1143)

Cisplatin administered as an IV infusion every 3 weeks (Q3W).

70 Gy given in 35 fractions over 7 weeks.

Intensity Modulation Radiation Therapy (IMRT)

Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Placebo

Medical Responsible

The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

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 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

EFS is the time from the date of randomization to the date of first record of disease progression or death.

OS is the time from randomization to death due to any cause.

PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)

ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).

CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).

Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.

Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)

Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H\&N35)

Spots Global Cancer Trial Database for intensity modulation radiation therapy (imrt)