Clinical Trials List
2022-08-31 - 2031-02-28
Phase III
Recruiting9
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 cisplatin
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tsung-Jang Yeh 無
- 蘇昶瑋 無
- Chih-Jen Huang 無
- 曾良鵬 無
- 高郁勛 無
- 莊舒婷 無
- Tzu-Yen Huang 無
- 許經偉 無
- 王緒佳 無
- 林裕 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王駿瑋 Division of Hematology & Oncology
- 蔡巧琳 Division of Hematology & Oncology
- 陳婉瑜 Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 賴詩璠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭乃銘 無
- 葉智華 無
- Hung-Ming Wang 無
- 黃祥富 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ling-Wei Wang 無
- 朱本元 無
- Mu-Hsin Chang 無
- 黃品逸 無
- 戴世光 無
- 胡育文 無
- Tsung-Lun Lee 無
- Tien-Hua Chen 無
- Yuan-Hung Wu 無
- Chia-Fan Chang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
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 10 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 according to national guidelines
Participants with adequate renal, hematologic and hepatic function as defined in the protocol
Other protocol-defined inclusion criteria could apply
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
Participants with incomplete surgery
Participants with recurrent or metastatic disease
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
Other protocol-defined exclusion criteria could apply
The Estimated Number of Participants
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Taiwan
45 participants
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Global
700 participants
