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
US Medical Information Kontakt: Phone: 888-275-7376 E-Mail: eMediUSA@emdserono.com» Kontaktdaten anzeigen Communication Center Kontakt: Phone: +49 6151 72 5200 E-Mail: service@emdgroup.com» Kontaktdaten anzeigen
Studienlocations (3 von 17)
Mount Sinai Comprehensive Cancer Center 33140 Miami Beach United StatesRekrutierend» Google-MapsKarmanos Cancer Institute - PARENT 48201 Detroit United StatesRekrutierend» Google-MapsMontefiore Medical Center PRIME 10467 Bronx United StatesRekrutierend» Google-Maps Ansprechpartner:
Avera McKennan Hospital and University Health Center 57105 Sioux Falls United StatesRekrutierend» Google-MapsUza - Parent Edegem BelgiumRekrutierend» Google-MapsCentre Hospitalier de l'Ardenne - PARENT Libramont BelgiumRekrutierend» Google-MapsVitaz Sint Niklaas BelgiumRekrutierend» Google-MapsPusan National University Hospital Busan Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner:
E-Mail: chyj@pusan.ac.kr» Ansprechpartner anzeigenSeoul National University Bundang Hospital Seongnam Korea, Republic ofRekrutierend» Google-MapsKonkuk University Medical Center Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System Seoul Korea, Republic ofRekrutierend» Google-MapsPusan National University Yangsan Hospital Yangsan-si Korea, Republic ofRekrutierend» Google-MapsICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica Girona SpainRekrutierend» Google-MapsClinica Universidad de Navarra (MAD) - Oncology Service Madrid SpainRekrutierend» Google-MapsHospital Universitario Virgen del Rocio - Oncology Service Sevilla SpainRekrutierend» Google-MapsKaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung TaiwanRekrutierend» Google-MapsTaipei Veterans General Hospital Taipei TaiwanRekrutierend» Google-Maps
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)
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
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)"
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