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)
Reason given: Study has crossed the pre-defined futility boundary at the Interim Analysis.
Key facts
- Where
- Ann Arbor, Ashland, Aurora, Birmingham, Boston, Charleston, Charlottesville, Cincinnati, Cleveland, Columbia, Columbus, Detroit, Fort Wayne, Gettysburg, Gilbert, Houston, Kansas City, La Jolla, Las Vegas, Louisville, Mineola, New Haven, New York, Oklahoma City, Philadelphia, Portland, Salt Lake City, San Francisco, St Louis, Tampa, Tucson, Washington D.C., Weeki Wachee, Whittier, and Winston-Salem, United StatesSee the 44 sites
- Phase
- Phase 3
Where in United States
- University South HospitalAnn Arbor, United StatesNo longer taking part
- Ashland-Bellefonte Cancer CenterAshland, United StatesNo longer taking part
- University of Colorado at Denver and Health Sciences CenterAurora, United StatesNo longer taking part
- The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)Birmingham, United StatesNo longer taking part
- Beth Israel Deaconess (BI Lahey)/Harvard Cancer CenterBoston, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Medical University of South Carolina - Hollings Cancer CenterCharleston, United StatesNo longer taking part
- University of Virginia Medical CenterCharlottesville, United StatesNo longer taking part
- University of Cincinnati Medical CenterCincinnati, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- University Hospital Cleveland Medical CenterCleveland, United StatesNo longer taking part
- University of Missouri - Ellis Fischel Cancer CenterColumbia, United StatesNo longer taking part
- Columbus Regional Research InstituteColumbus, United StatesNo longer taking part
- IACT Health - John B. Amos Cancer CenterColumbus, United StatesNo longer taking part
- Ohio State UniversityColumbus, United StatesNo longer taking part
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
- Inventa Center for Cancer Research At Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesNo longer taking part
- Gettysburg Cancer CenterGettysburg, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, United StatesNo longer taking part
- MD AndersonHouston, United StatesNo longer taking part
- MidAmerica Cancer CareKansas City, United StatesNo longer taking part
- UC San Diego Moores Cancer CenterLa Jolla, United StatesNo longer taking part
- Comprehensive Cancer Center of Nevada (Southern Hills) (USA)Las Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of NevadaLas Vegas, United StatesNo longer taking part
- Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital CampusLouisville, United StatesNo longer taking part
- NYU Langone Hospital-Long Island OncologyMineola, United StatesNo longer taking part
- Yale Cancer CenterNew Haven, United StatesNo longer taking part
- Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesNo longer taking part
- NYU Grossman School of MedicineNew York, United StatesNo longer taking part
- University of Oklahoma Health Sciences Center, Stephenson Cancer CenterOklahoma City, United StatesNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, United StatesNo longer taking part
- Providence Portland Medical CenterPortland, United StatesNo longer taking part
- IHO Corporation/Utah Cancer SpecialistsSalt Lake City, United StatesNo longer taking part
- Regents of the University of CaliforniaSan Francisco, United StatesNo longer taking part
- UCSFSan Francisco, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- University of Arizona Cancer CenterTucson, United StatesNo longer taking part
- Lombardi Comprehensive Cancer Center, Georgetown University Medical CenterWashington D.C., United StatesNo longer taking part
- ASCLEPES Research CentersWeeki Wachee, United StatesNo longer taking part
- The Oncology Institute of Hope & InnovationWhittier, United StatesNo longer taking part
- Wake Forest University School of MedicineWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- EMD Serono Research & Development Institute, Inc.
- Trial code
- NCT04459715
- Record updated
- 8 October 2025
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: 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; Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.); 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; 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; Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site; other protocol defined exclusion criteria may apply.