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JOURNAL ONKOLOGIE – STUDIE

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

Rekrutierend

NCT-Nummer:
NCT06056310

Studienbeginn:
Januar 2024

Letztes Update:
29.03.2024

Wirkstoff:
Xevinapant, Cisplatin

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
EMD Serono Research & Development Institute, Inc.

Collaborator:
Merck KGaA, Darmstadt, Germany

Studienleiter

Medical Responsible
Study Director
EMD Serono Research & Development Institute, Inc.

Kontakt

Studienlocations
(3 von 17)

Mount Sinai Comprehensive Cancer Center
33140 Miami Beach
United StatesRekrutierend» Google-Maps
Karmanos Cancer Institute - PARENT
48201 Detroit
United StatesRekrutierend» Google-Maps
Avera McKennan Hospital and University Health Center
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Centre Hospitalier de l'Ardenne - PARENT
Libramont
BelgiumRekrutierend» Google-Maps
Seoul National University Bundang Hospital
Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Konkuk University Medical Center
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
Yangsan-si
Korea, Republic ofRekrutierend» Google-Maps
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio - Oncology Service
Sevilla
SpainRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Number of Participants with Dose limiting toxicity (DLT)-like events (Time Frame - From Day 1 up to 5 Weeks)



Secondary outcome:

1. Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE) (Time Frame - From Day 1 up to 18 weeks (Each cycle is of 3 Weeks))

2. Absolute values and changes in estimated glomerular filtration rate (eGFR) (Time Frame - From Screening up to Cycle 3 Day 4 (Day 67))

3. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator (Time Frame - Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years)

4. Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator (Time Frame - Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years)

5. Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator (Time Frame - 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.

6. Time to Subsequent Systemic Cancer Treatments (Time Frame - 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)

Geprüfte Regime

  • Xevinapant (Debio 1143):
    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

Quelle: ClinicalTrials.gov


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