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A Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy



August 2020

Letztes Update:

Debio 1143, Cisplatin, Placebo

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck


Erwachsene (18+)

Phase 3

Debiopharm International SA

GORTEC (Head and Neck Oncology and Radiotherapy Group)


Studienlocations (3 von 42)

Department of radiation oncology, University Hospital Essen
45122 Essen
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
68167 Mannheim
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum der Landeshauptstadt Stuttgart gKAöR
70174 Stuttgart
GermanyNoch nicht rekrutierend» Google-Maps
ASCLEPES Research Centers
34607 Weeki Wachee
United StatesNoch nicht rekrutierend» Google-Maps
Columbus Regional Research Institute
31904 Columbus
United StatesRekrutierend» Google-Maps
IACT Health, John B. Amos Cancer Center
31904 Columbus
United StatesNoch nicht rekrutierend» Google-Maps
Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
United StatesRekrutierend» Google-Maps
Ashland-Bellefonte Cancer Center
41101 Ashland
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
Dana-Farber Cancer Institute
45267 Cincinnati
United StatesNoch nicht rekrutierend» Google-Maps
Gettysburg Cancer Center
17325 Gettysburg
United StatesRekrutierend» Google-Maps
St Vincents Hospital Melbourne
03065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Centre
8006 Victoria
AustraliaNoch nicht rekrutierend» Google-Maps
Landeskrankenhaus Salzburg
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-Maps
CHU UCL Namur Site Sainte Elisabeth
5000 Namur
BelgiumNoch nicht rekrutierend» Google-Maps
Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Caridade de Ijui, Avenida David Jose Martins
98700-000 Ijuí
BrazilNoch nicht rekrutierend» Google-Maps
Centro Gaúcho Integrado, Rua Costa
90110-270 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
15090-000 São José Do Rio Preto
BrazilNoch nicht rekrutierend» Google-Maps
Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
90050-170 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
09060-650 Santo André
BrazilNoch nicht rekrutierend» Google-Maps
High Technology Hospital Medcenter
6000 Batumi
GeorgiaNoch nicht rekrutierend» Google-Maps
Evex Hospitals Oncology Center
4600 Kutaisi
GeorgiaRekrutierend» Google-Maps
Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
0112 Tbilisi
GeorgiaRekrutierend» Google-Maps
Institute of Clinical Oncology
0159 Tbilisi
GeorgiaRekrutierend» Google-Maps
Simon Khechinashvili University Clinic
0179 Tbilisi
GeorgiaRekrutierend» Google-Maps
LEPL First University Clinic of Tbilisi State Medical University
141 Tbilisi
GeorgiaRekrutierend» Google-Maps
Orszagos Onkologiai Intezet Sugarterapias Osztaly
1122 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Uzsoki Utcai Korhaz Onkologiai Osztaly
1145 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Petz Aladár Megyei Kórház Onkoradiológiai Osztály
9024 Győr
HungaryNoch nicht rekrutierend» Google-Maps
Pusan National University Hospital
49241 Busan
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Pusan National University Yangsan Hospital, Oncol & Hematology
50612 Yangsan
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
3010 Bern
SwitzerlandNoch nicht rekrutierend» Google-Maps
Hopitaux Universitaires de Geneve
1205 Geneve
SwitzerlandNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois Lausanne
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Medical center ASKLEPION LLC
8173 Khodosivka
UkraineNoch nicht rekrutierend» Google-Maps
Kiev City Clinical Oncology Centre
3115 Kiev
UkraineNoch nicht rekrutierend» Google-Maps
Medical center of Yuriy Spizhenko, Soborna Vulytsia
8111 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
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Brief Summary:

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs

placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of

the head and neck (LA-SCCHN).


Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

- Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous

Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb

according to the American Joint Committee on Cancer(AJCC))/Classification of malignant

tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant

metastasis (TNM) Staging System, 8th Ed.) suitable for definitive ChemoRadiotherapy

(CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx

- For OroPharyngeal Cancer (OPC) participants, primary tumors must be human

papillomavirus (HPV)-negative as determined by p16 expression using


- Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by

computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on

RECIST v 1.1

- Peripheral neuropathy < grade 2

- Adequate hematologic, renal and hepatic function

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 Ed.)

- Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and

neck region which may jeopardize the primary tumor irradiation plan, or any other

prior SCCHN systemic treatment, including investigational agents

- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless

adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0


- Known allergy to Debio 1143, cisplatin or any excipient known to be present in

Debio1143 or in the placebo formulation.


Primary outcome:

1. Event-Free Survival (EFS) (Time Frame - Up to 5 years):
EFS is the time from the date of randomization to the date of first record of disease progression or death.

Secondary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to 5 years):
PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)

2. Overall survival (OS) (Time Frame - Up to 5 years):
OS is the time from randomization to death due to any cause.

3. Locoregional Control (LRC) (Time Frame - From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years))

4. Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure (Time Frame - From signed informed consent to EOS (within 6.8 years))

5. Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom (Time Frame - Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)):
Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)

6. Changes from Baseline in Swallowing and Pain Symptoms (Time Frame - Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)):
Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)


  • Experimental: Debio 1143
    Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Debio 1143 Monotherapy period (Cycles 4-6): • Debio 1143
  • Active Comparator: Placebo
    Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo

Geprüfte Regime

  • Debio 1143:
    Debio 1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.
  • Cisplatin:
    Cisplatin administered as an IV infusion every 3 weeks (Q3W).
  • Intensity Modulation Radiation Therapy (IMRT):
    70 Gy given in 35 fractions over 7 weeks
  • Placebo:
    Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.


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