The trial is taking place at:
C

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

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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)

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Merck KGaA (EMD Serono)

Status and phase

Active, not recruiting
Phase 3

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Drug: Placebo
Drug: Xevinapant (Debio 1143)
Drug: Cisplatin
Radiation: Intensity Modulation Radiation Therapy (IMRT)

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT04459715
Debio 1143-SCCHN-301
2020-000377-25 (EudraCT Number)
MS202359_0006

Details and patient eligibility

About

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).

Enrollment

730 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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 criteria

* 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

730 participants in 2 patient groups

Xevinapant (Debio 1143)
Experimental group
Description:
Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Xevinapant (Debio 1143) Monotherapy period (Cycles 4-6): • Xevinapant (Debio 1143)
Treatment:
Radiation: Intensity Modulation Radiation Therapy (IMRT)
Drug: Cisplatin
Drug: Xevinapant (Debio 1143)
Placebo
Active Comparator group
Description:
Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo
Treatment:
Radiation: Intensity Modulation Radiation Therapy (IMRT)
Drug: Cisplatin
Drug: Placebo

Trial contacts and locations

286

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Data sourced from clinicaltrials.gov

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