resected SCCHN, who are at high risk for relapse and are ineligible for high-dose cisplatin
Conditions
Interventions
Experimental arm:
Concomitant chemo-radiation therapy period (Cycles 1-3):
-Xevinapant: Xevinapant administrated as oral solution from Day 1 to 14, every 21-day cycle.
-Intensity Modulation Radiation
Sponsors
Suzuki Tomoya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have ECOG PS 0-1 2. Participants with HPV-negative oropharynx cancers as determined by testing p16 expression using immunohistochemistry (IHC), with oral cavity, hypopharynx or larynx cancers with the following pathological staging (pTNM stage according to the American Joint Committee on Cancer AJCC/TNM Staging System 8th Edition): -pIII or -pIVA or pIVB OR Participants with HPV-positive oropharynx cancers, as determined by testing p16 expression using IHC, must be smokers > 25 Pack-Year, and must have the following pTNM stage (according to the AJCC/TNM Staging System 8th Edition): -pT3 and pN2 or -pT4 and pN2 OPC participants must have known HPV status as determined by p16 expression using IHC 3. Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: -30 = Grade 2 -If ? 70 years, unfit according to G8 questionnaire (Score <= 14) 4. Have adequate hematologic and hepatic function 5. Other
Exclusion criteria
Exclusion criteria: 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.Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site. 3.Participant with incomplete surgery i.e. R2 resection 4.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. 5.Participation in any clinical study within 28 days prior to screening or during participation in this study. 6.Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast-enhanced CT scans. 7.Known allergy to xevinapant or any excipient known to be present in xevinapant or in the placebo formulation. 8.Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS) | — |
Countries
Argentina, Belgium, Brazil, China, Germany, Italy, Japan, Portugal, Romania, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactTomoya Suzuki
Merck Biopharma Co., Ltd.
Outcome results
None listed