A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplati
- Conditions
- Locally Advanced Tumor / Locally Advanced Cancer10027656
- Registration Number
- NL-OMON56150
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
• Participants with Eastern Cooperative Oncology Group Performance Status (ECOG
PS) 0-2 and able to tolerate standard of care IMRT treatment according to
Investigator assessment.
• 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) or magnetic
resonance imaging (MRI) 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: estimated glomerular filtration rate (eGFR) < 60
milliliter per minute per 1.73 meter square (mL/min /1.73 m^2); History of
hearing impairment, defined as Grade >= 2 audiometric hearing loss or tinnitus
Grade >=2. 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) or ineligible
for cisplatin treatment due to age limit to national guidelines
• Participants with adequate hematologic, renal and hepatic function as defined
in the protocol
• Other protocol-defined inclusion criteria could apply
• 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 recurrent or metastatic disease
• Other protocol-defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method