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)
Megadott ok: Study has crossed the pre-defined futility boundary at the Interim Analysis.
Key facts
- Where
- Budapest, Győr, Pécs és Szeged, MagyarországSee the 5 sites
- Phase
- 3. fázis
Where in Magyarország
- Orszagos Onkologiai Intezet Sugarterapias OsztalyBudapest, MagyarországNo longer taking part
- Uzsoki Utcai Korhaz Onkologiai OsztalyBudapest, MagyarországNo longer taking part
- Petz Aladár Megyei Kórház Onkoradiológiai OsztályGyőr, MagyarországNo longer taking part
- Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias IntazetPécs, MagyarországNo longer taking part
- Szegedi Tudományegyetem ÁOK Onkoterápiás KlinikaSzeged, MagyarországNo longer taking part
Trial details
- Who runs it
- EMD Serono Research & Development Institute, Inc.
- Trial code
- NCT04459715
- Record updated
- 2025. október 8.
- 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.