Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Cancer

In brief

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Key facts

Study ID

NCT05386550

Run by

EMD Serono Research & Development Institute, Inc.

People needed

166

Starts

2022-10-06

Expected to finish

2024-08-27

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham - Dept of Radiation Oncology — Birmingham, Alabama, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• UC Health — Aurora, Colorado, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Perlmutter Cancer Center at NYU Langone Hospital ae Long Island — New York, New York, United States
• Montefiore Medical Center Radiology — The Bronx, New York, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States
• Prisma Health Cancer Institute, ITOR, CRU — Greenville, South Carolina, United States
• Instituto de Oncologia Angel Roffo — Ciudad Autonoma Buenos Aires, Argentina
• Centro Oncologico Riojano Integral (CORI) — La Rioja, Argentina
• CEMAIC- Centro Medico Privado — Las Margaritas, Argentina
• Fundacion Scherbovsky — Mendoza, Argentina
• Clinica Viedma S.A. — Viedma, Argentina
• Universitatsklinikum Graz — Graz, Austria
• Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO — Linz, Austria
• LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie — Salzburg, Austria
• Institut Jules Bordet - Medical Oncology — Anderlecht, Belgium
• Cliniques Universitaires Saint-Luc - STL — Brussels, Belgium
• Antwerp University Hospital (UZA Parent) — Edegem, Belgium
• Vitaz — Sint-Niklaas, Belgium
• Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor — Barretos, Brazil
• Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer — Curitiba, Brazil
• Jiangxi Cancer Hospital — Nanchang, China

Full record on ClinicalTrials.gov

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