Spots Global Cancer Trial Database for Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
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Trial Identification
Brief Title: Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
Official Title: A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)
Study ID: NCT06056310
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Karmanos Cancer Institute - PARENT, Detroit, Michigan, United States
Montefiore Medical Center PRIME, 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, Gent, , 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, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Konkuk University Medical Center, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan-si, , Korea, Republic of
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, Sevilla, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Medical Responsible
Affiliation: EMD Serono Research & Development Institute, Inc.
Role: STUDY_DIRECTOR
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