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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
Karmanos Trial ID
2022-090
NCT ID
NCT05386550
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Ammar
Sukari, M.D.
Oncology - Medical
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Objective:
Primary Objective:
To demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy
Secondary Objectives:
To demonstrate improvement in OS with xevinapant compared to placebo when added to RT followed by subsequent anticancer therapy.
To evaluate time to subsequent cancer treatments in participants treated with xevinapant compared to placebo when added to RT.
To evaluate the safety and tolerability of xevinapant compared to placebo when added to RT.
To evaluate xevinapant compared to placebo when added to RT followed by xevinapant onotherapy in terms of patient-reported head and neck pain, swallowing, and speech as measured by the EORTC H&N35 sub scales, patient-reported fatigue, physical function, and global health status as measured by the EORTC QLQ C-30 sub scales and EQ5D-5L VAS.
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion 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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Other
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Radiation Therapy
Drugs
Placebo; Xevinapant
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