Status:
TERMINATED
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)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Merck KGaA, Darmstadt, Germany
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 h...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT04459715
Start Date
August 7 2020
End Date
September 18 2024
Last Update
October 8 2025
Active Locations (288)
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1
The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham, Alabama, United States, 35233
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093