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)

TerminadoFase 3ClinicalTrials.gov

ID: NCT04459715Tipo: INTERVENTIONALInicio: 7 de ago de 2020Fin estimado: 18 de sept de 2024

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Xevinapant (Debio 1143)

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

drug

Cisplatin

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

radiation

Intensity Modulation Radiation Therapy (IMRT)

70 Gy given in 35 fractions over 7 weeks.

drug

Placebo

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

Ubicaciones

Hospital Aleman

Buenos Aires, Argentina

Instituto Medico Especialazado Alexander Fleming

Buenos Aires, Argentina

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Instituto de Oncologia de Rosario

Santa Fe, Argentina

Clinica Viedma

Viedma, Argentina

Patrocinadores

PrincipalEMD Serono Research & Development Institute, Inc.

ColaboradorGORTEC (Head and Neck Oncology and Radiotherapy Group)

ColaboradorMerck KGaA, Darmstadt, Germany

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