Trial purpose
Cancer treatment
Tumor type
Head and Neck
Age
18+
Clinical summary
Summary
Eligible patients will be randomised to receive concomitant chemo-radiation therapy containing radiotherapy, Cisplatin and Debio 1143 (or a matched placebo) in Cycles 1-3, followed by Debio 1143 (or a matched placebo) monotherapy in Cycles 4-6.
Conditions
This trial is treating people with squamous cell carcinoma of the head and neck
Eligibility
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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Scientific Title
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)
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