Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Conditions
Interventions
Experimental arm:
Concomitant chemo-radiation therapy period (Cycles 1-3):
-Debio1143 (Xevinapant): Debio1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.
-Cisplatin: Cisplatin
Sponsors
Suzuki Tomoya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. - Histologically confirmed diagnosis in previously untreated LA-SCCHN patient (stage III, IVA or IVB according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Edition.) suitable for definitive CRT, of at least one of the following sites: oropharynx, hypopharynx, and larynx. - For OroPharyngeal Cancer (OPC) patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry. - Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on Response evaluation sriteria in solid tumors (RECIST ) version 1.1. - Peripheral neuropathy less than or equal to (<=) grade 2. - Adequate hematologic, renal, and hepatic function. - Other protocol defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: -Primary tumor of nasopharyngeal, 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival (EFS) [Time Frame: Up to 5 years ] EFS is the time from the date of randomization to the date of first record of disease progression or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) - Progression-Free Survival (PFS) - Locoregional Control (LRC) - Objective Response Rate (ORR) - Complete Response Rate (CRR) - Duration of Response (DOR) - Number of Participants with Radical Salvage Surgery - Time to Subsequent Systemic Cancer Treatments - Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure - Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom - Changes from Baseline in Swallowing and Pain Symptoms | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Poland, Portugal, Republic of Korea, Russia, Spain, Switzerland, Taiwan, UK, Ukraine, USA
Contacts
Public ContactClinical Trial Information for Contact
Merck Biopharma Co., Ltd.
Outcome results
None listed