Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT06056310
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
- 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
- Other protocol defined inclusion criteria could apply
- Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
- 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
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xevinapant + Cisplatin + IMRT intensity-modulated radiation therapy (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 + Cisplatin + IMRT Cisplatin 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 + Cisplatin + IMRT 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose limiting toxicity (DLT)-like events From Day 1 up to 5 Weeks
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE) From Day 1 up to 18 weeks (Each cycle is of 3 Weeks) Absolute values and changes in estimated glomerular filtration rate (eGFR) From Screening up to Cycle 3 Day 4 (Day 67) Time to Subsequent Systemic Cancer Treatments From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study, assessed approximately up to 1.6 years Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study assessed approximately up to 1.6 years LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.
Trial Locations
- Locations (23)
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Montefiore Medical Center PRIME
🇺🇸Bronx, New York, United States
Universitair Ziekenhuis Gent - Medical Oncology
🇧🇪Gent, Belgium
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Vitaz
🇧🇪Sint Niklaas, Belgium
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
Clinica Universidad de Navarra (MAD) - Oncology Service
🇪🇸Madrid, Spain
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
🇪🇸Girona, Spain
Hospital Universitario Fundacion Jimenez Diaz - Oncology
🇪🇸Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Hospital Universitario Virgen del Rocio - Oncology Service
🇪🇸Sevilla, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Karmanos Cancer Institute - PARENT
🇺🇸Detroit, Michigan, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Centre Hospitalier de l'Ardenne - PARENT
🇧🇪Libramont, Belgium
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Uza - Parent
🇧🇪Edegem, Belgium