EUCTR2022-001144-18-NL进行中（未招募）1 期
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 - Phase III xevinapant and radiotherapy in resected LA SCCH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 according to national guidelines
- •Participants with adequate hematologic, renal 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
排除标准
- •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
研究者
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