Not currently recruiting at UCSD

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

a study on Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Head and Neck Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Loren Mell
Headshot of Loren Mell
Loren Mell

Description

Summary

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.

Official Title

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 (XRAY VISION)

Keywords

Head and Neck Cancer, Adjuvant radiotherapy (RT), Stage III, Stage IVA, Stage IVB, Oral cavity, Oropharynx, Larynx, Hypopharynx, Unfit, Head and Neck Neoplasms, Xevinapant (Debio 1143), IMRT, Xevinapant (Debio 1143) + IMRT

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • 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 m2); 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)
  • Participants with adequate renal, hematologic and hepatic function as defined in the protocol
  • Other protocol-defined inclusion criteria could apply

You CAN'T join 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 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

  • UC San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States

Lead Scientist at UCSD

  • Loren Mell
    Professor, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 176 research publications. Research interests: Personalized Medicine · Clinical Trials · Risk Modeling · Immune System · Imaging · Immunotherapy

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
Trial Awareness and Transparency website US Medical Information website, Medical Resources
ID
NCT05386550
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated