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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

The primary objective of the study was 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).

Key facts

Study ID

NCT04459715

Run by

EMD Serono Research & Development Institute, Inc.

People needed

730

Starts

2020-08-07

Expected to finish

2024-09-18

Last updated by the study team

2025-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
• Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Edition.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx
• For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by p16 expression using immunohistochemistry
• Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1
• Peripheral neuropathy less than (<) grade 2
• Adequate hematologic, renal and hepatic function
• Other protocol defined inclusion criteria may apply

You may not qualify if…

• Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site
• Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)
• Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
• Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization
• Known allergy to Xevinapant (Debio 1143), cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation
• other protocol defined exclusion criteria may apply

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Regents of the University of California — San Francisco, California, United States
• UCSF — San Francisco, California, United States
• The Oncology Institute of Hope & Innovation — Whittier, California, United States
• University of Colorado at Denver and Health Sciences Center — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Lombardi Comprehensive Cancer Center, Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• ASCLEPES Research Centers — Weeki Wachee, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• IACT Health, John B. Amos Cancer Center — Columbus, Georgia, United States
• Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Ashland-Bellefonte Cancer Center — Ashland, Kentucky, United States
• Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University South Hospital — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Karmanos Cancer institute — Detroit, Michigan, United States
• University of Missouri - Ellis Fischel Cancer Center — Columbia, Missouri, United States
• MidAmerica Cancer Care — Kansas City, Missouri, United States
• The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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