Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
NCT ID: NCT06056310
Last Updated: 2025-09-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2024-01-18
2024-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Xevinapant + Cisplatin + IMRT
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
Xevinapant
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
Cisplatin
Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).
intensity-modulated radiation therapy (IMRT)
Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week
Interventions
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Xevinapant
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
Cisplatin
Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).
intensity-modulated radiation therapy (IMRT)
Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer \[AJCC\]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
* Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
* Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
* Adequate hematological, hepatic, and renal function as defined in the protocol
Exclusion Criteria
* Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
* Existing need of a hearing aid or greater than or equal to (\>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
* Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
* Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc.
Locations
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Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Karmanos Cancer Institute - PARENT
Detroit, Michigan, United States
Montefiore Medical Center PRIME
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Uza - Parent
Edegem, , Belgium
Universitair Ziekenhuis Gent - Medical Oncology
Ghent, , Belgium
Centre Hospitalier de l'Ardenne - PARENT
Libramont, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Pusan National University Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona, , Spain
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz - Oncology
Madrid, , Spain
Hospital Universitario Virgen del Rocio - Oncology Service
Seville, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2023-505796-76-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS202359_0025
Identifier Type: -
Identifier Source: org_study_id
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