A clinical study comparing efficacy and safety of xevinapant against placebo when given with radiotherapy in participants who had their locally advanced squamous cell carcinoma of the head and neck removed by surgery, are at high risk for the cancer to return and who cannot be treated with high-dose cisplatin.
- Conditions
- Resected squamous cell carcinoma of the head and neckMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-001144-18-PT
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
• 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 (<=) 1 millimeter (mm)
• Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: 30 < estimated glomerular filtration rate (eGFR) < 60
milliliter per minute per 1.73 meter square (mL/min /1.73 m^2); History of hearing loss, defined as Grade >= 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 <= 14)
• Participants with adequate hematologic and hepatic function as defined in the protocol
• Other protocol-defined inclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 385
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method