Resected squamous cell carcinoma of the head and neck MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Xevinapant
Product Code: MSC2735845A
Pharmaceutical Form: Oral solution
INN or Proposed INN: Xevinapant
Current Sponsor code: MSC2735845A
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Merck Healthcare KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 • Participants with histologically confirmed squamous cell carcinoma with one of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx. Participants have received surgery with curative intent on these sites in the past 4 to 8 weeks before start of treatment (Cycle 1 Day 1) • Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry ICH) • Participants with no residual disease by computed tomography (CT) and 2-deoxy-2-[fluorine-18] fluoro-D-glucose positron emission tomography (18F-FDG-PET) and have a high risk of relapse with 1 or 2 of the following criteria, confirmed by local histopathology: • nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin less than or equal to (= 2 audiometric hearing loss. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy > = Grade 2 and if >= 70 years, unfit according to G8 questionnaire (Score =65 years) yes F.1.3.1 Number of subjects for this age range 385
Exclusion criteria
Exclusion criteria: • Any condition, including any uncontrolled disease state other than SCCHN that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation • Participant with incomplete surgery • Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site • Prior definitive, neoadjuvant, concurrent or adjuvant (C)RT to the head and neck region which may jeopardize the primary tumor irradiation plan,or any other prior SCCHN systemic treatment, including investigational agents • Participation in any interventional clinical study within 28 days prior to screening or during participation in this study • Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast enhanced CT scans • Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation • Participants with metastatic disease • Other protocol-defined exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy.;Secondary Objective: - To demonstrate improvement in OS with xevinapant compared to placebo when added to RT followed by subsequent anticancer therapy - To evaluate time to subsequent cancer treatments in participants treated with xevinapant compared to placebo when added to RT - To evaluate the safety and tolerability of xevinapant compared to placebo when added to RT - To evaluate xevinapant compared to placebo when added to RT followed by xevinapant monotherapy in terms of patient-reported head and neck pain, swallowing, and speech as measured by the EORTC H&N35 sub scales, patient-reported fatigue, physical function, and global health status as measured by the EORTC QLQ C-30 sub scales and EQ-5D-5L VAS;Primary end point(s): Disease-Free Survival (DFS) ;Timepoint(s) of evaluation of this end point: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival (OS) 2. Time to Subsequent Cancer Treatments 3. Number of Participants with Adverse Events (AEs) and Treatment-related AEs 4. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score 5. Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score 6. Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS);Timepoint(s) of evaluation of this end point: 1. Time from randomization to death from any cause, assessed up to 5 years 2. Time from randomization to the start of first subsequent cancer treatment, assessed up to 5 years 3. Time from randomization until end of study (up to 5 years) 4. Baseline up to follow-up (5 years) 5. Baseline up to follow-up (5 years) 6. Baseline up to follow-up (5 years) | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactCommunication Centre
Merck Healthcare KGaA
Outcome results
None listed