Clinical trial NCT06056310: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: Unresected
Combination with CRT
Stage III
Stage IVA
Stage IVB
Oropharynx
Hypopharynx
Larynx
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2023-09-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants with Dose limiting toxicity (DLT)-like events
timeFrame: From Day 1 up to 5 Weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE)
timeFrame: From Day 1 up to 18 weeks (Each cycle is of 3 Weeks)
measure: Absolute values and changes in estimated glomerular filtration rate (eGFR)
timeFrame: From Screening up to Cycle 3 Day 4 (Day 67)
measure: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator
timeFrame: Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years
measure: Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator
timeFrame: Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years
measure: Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator
timeFrame: 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
measure: Time to Subsequent Systemic Cancer Treatments
timeFrame: 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
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute - PARENT
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital and University Health Center
state: South Dakota
city: Edegem
country: Belgium
facility: Uza - Parent
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent - Medical Oncology
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne - PARENT
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Girona
country: Spain
facility: ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra (MAD) - Oncology Service
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz - Oncology
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - Oncology Service
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: EMD Serono Research & Development Institute, Inc.
name: Medical Responsible
role: STUDY_DIRECTOR
References: