Phase III study to assess efficacy and safety of Xevinapant and Radiotherapy in participants with resected Squamous Cell Carcinoma of Head & Neck.
- Conditions
- Health Condition 1: C760- Malignant neoplasm of head, face and neck
- Registration Number
- CTRI/2023/04/051940
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
2. 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)
3. Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry (ICH)
4. 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)
5. Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute per 1.73 meter square (mL per min per 1.73 m2); History of hearing impairment, defined as Grade more than or equal to 2 audiometric hearing loss or tinnitus Grade more than or equal to 2. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy more than or equal to Grade 2 and if more than or equal to 70 years, unfit according to G8 questionnaire (Score less than or equal to 14)
6. Participants with adequate renal, hematologic and hepatic function as defined in the protocol
7. Other protocol-defined inclusion criteria could apply
1. 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
2. Participants with incomplete surgery
3. Participants with metastatic disease
4. Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site
5. 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
6. Participation in any interventional clinical study within 28 days prior to screening or during participation in this study
7. Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast-enhanced CT scans
8. Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation
9. Other protocol-defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Disease-Free Survival (DFS) <br/ ><br> [Time Frame: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years]Timepoint: •Disease-Free Survival (DFS) <br/ ><br> [Time Frame: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years]
- Secondary Outcome Measures
Name Time Method •To demonstrate improvement in Overall Survival (OS) <br/ ><br>•To evaluate time to subsequent cancer treatments <br/ ><br>•To evaluate the safety and tolerability of xevinapant compared to placebo when added to RT <br/ ><br> <br/ ><br>Timepoint: •Time from date of randomization to death <br/ ><br>•Time from randomization to start of first subsequent cancer treatment <br/ ><br>•Occurrence of AEs and treatment-related AEs <br/ ><br> <br/ ><br>