Clinical trial • Phase III • Oncology

DURVALUMAB for Esophageal squamous cell carcinoma|Locally advanced unresectable esophageal squamous cell carcinoma

Phase III trial of DURVALUMAB for Esophageal squamous cell carcinoma|Locally advanced unresectable esophageal squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Esophageal squamous cell carcinoma|Locally advanced unresectable esophageal squamous cell carcinoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
14-03-2024
First CTIS Authorization Date
08-04-2024

Trial design

Randomised, placebo + concurrent chemoradiation (placebo described as: 26 mm histidine/histidine-hcl, 275 mm trehalose dihydrate, 0.02% (w/v) polysorbate 80, ph 6.0). comparator arm receives placebo + definitive chemoradiation therapy. dose and schedule of placebo not specified in available data; chemoradiation regimen details not specified in ctis summary.-controlled Phase III trial across 22 sites in Spain, Poland, France and others.

Randomised
Yes
Comparator
Placebo + concurrent chemoradiation (Placebo described as: 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0). Comparator arm receives placebo + definitive chemoradiation therapy. Dose and schedule of placebo not specified in available data; chemoradiation regimen details not specified in CTIS summary.
Target Sample Size
475

Eligibility

Recruits 475 Vulnerable population selected. Informed consent is obtained from adult participants (minimum age ≥18). Subject information and informed consent forms are available (documents listed in CTIS include L1_SIS and ICF Adult, L1_SIS and ICF Pregnant, country-specific ICFs such as Polish and BE language versions). Additional information materials for pregnant partners and optional genetic testing are provided. No assent for minors is applicable because minimum age is 18..

Vulnerable Population
Vulnerable population selected. Informed consent is obtained from adult participants (minimum age ≥18). Subject information and informed consent forms are available (documents listed in CTIS include L1_SIS and ICF Adult, L1_SIS and ICF Pregnant, country-specific ICFs such as Polish and BE language versions). Additional information materials for pregnant partners and optional genetic testing are provided. No assent for minors is applicable because minimum age is 18.

Inclusion criteria

  • {"criterion_text":"- 18 years or older at the time of signing the ICF.\n- Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).\n- Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.\n- Patients with at least an evaluable lesion per RECIST 1.1\n- Mandatory provision of available tumor tissue for PD-L1 expression analysis.\n- ECOG PS 0 or 1.\n- Adequate organ and marrow function.\n- Life expectancy of more than 3 months."}

Exclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.\n- Prior anti-cancer treatment for ESCC.\n- Patient with a great risk of perforation and massive bleeding.\n- History of allogeneic organ transplantation.\n- Active or prior documented autoimmune or inflammatory disorders.\n- Uncontrolled intercurrent illness.\n- History of another primary malignancy.\n- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.\n- Known allergy or hypersensitivity to any of the study interventions or any of the study interventions excipients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP≥1% tumors","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1"}

Secondary endpoints

  • {"endpoint_text":"- PFS using BICR assessments according to RECIST 1.1 in all randomized patients\n- OS, OS36, PFS2, APF24, ORR, DoR, DCR and TTP per RECIST 1.1 as assessed by BICR in all randomized patients and in patients with PD-L1 TAP≥1% tumors\n- Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by EORTC QLQ-C30 and QLQ-OES18\n- Concentration of durvalumab in blood\n- ADA in all randomized patients","definition_or_measurement_approach":"Endpoints assessed per RECIST 1.1 via BICR where specified; HRQoL measured by EORTC QLQ-C30 and QLQ-OES18; PK measured as blood concentration of durvalumab; immunogenicity assessed by anti-drug antibodies (ADA) in randomized patients."}

Recruitment

Planned Sample Size
475
Recruitment Window Months
32
Consent Approach
Informed consent obtained from adult participants (age ≥18). Subject information and informed consent forms available in multiple country/language versions (examples in CTIS: L1_SIS and ICF Adult, L1_SIS and ICF Adult PL (Polish), L1_SIS and ICF Adult BE English/French/Dutch, L1_SIS and ICF Pregnant, and other country-specific versions). Additional informational materials provided for pregnant partners and optional genetic testing. Consent provided by participant; no assent process described for minors (minimum age 18).

Geography

Total Number Of Sites
22
Total Number Of Participants
48

Spain

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
20-11-2024
Processing Time Days
238
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
Hospital General Universitario Reina Sofia
Department Name
Oncologia
Contact Person Name
Rosa Maria Rodriguez Alonso
Contact Person Email
rosarodriguezalonso@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncologia
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Contact Person Name
Daniel Alejandro Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Universitario La Paz
Department Name
Oncologia
Contact Person Name
Ana Belen Custodio Carretero
Contact Person Email
anabcustodio@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncologia
Contact Person Name
Aitana Calvo Ferrandiz
Contact Person Email
aitanacalvo@hotmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Oncologia
Contact Person Name
Virginia Arrazubi Arrula
Contact Person Email
varrazubi@gmail.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncologia
Contact Person Name
Roberto Antonio Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital General Universitario Gregorio Maranon (duplicate entry in list)
Department Name
Oncologia
Contact Person Name
Aitana Calvo Ferrandiz
Contact Person Email
aitanacalvo@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
11-01-2025
Processing Time Days
290
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjanwyrwicz@gmail.com
Site Name
Katowickie Centrum Onkologii
Department Name
Zaklad Radioterapii
Contact Person Name
Robert Kwiatkowski
Contact Person Email
rkwiat11@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Cracow)
Contact Person Name
Malgorzata Klimek

France

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
726
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical Oncology
Contact Person Name
Meher BEN ABDELGHANI
Contact Person Email
m.ben.abdelghani@icans.eu
Site Name
Hopital Prive Jean Mermoz
Department Name
Oncology
Contact Person Name
Pascal ARTRU
Contact Person Email
dr.artru@wanadoo.fr
Site Name
CHU De Rouen
Department Name
Gastro enterology
Contact Person Name
David SEFRIOUI
Contact Person Email
david.sefrioui@chu-rouen.fr
Site Name
Courlancy Sante
Department Name
Oncology
Contact Person Name
William MINA
Contact Person Email
wmina@centre-icone.fr
Site Name
Institut Gustave Roussy
Department Name
Digestive Oncology
Contact Person Name
Michel DUCREUX
Site Name
Besancon University Hospital Center
Department Name
Oncology
Contact Person Name
Christophe BORG
Contact Person Email
christophe.borg@efs.sante.fr
Site Name
HPM Nord
Department Name
Oncology
Contact Person Name
Come DE METZ
Contact Person Email
cdemetz@clinique-psv.fr

Belgium

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
776
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Medical Oncology
Contact Person Name
Jean-Charles Goeminne
Site Name
Grand Hopital De Charleroi
Department Name
Service d'oncologie et hématologie
Contact Person Name
Javier Carrasco
Contact Person Email
javier.CARRASCO@ghdc.be
Site Name
UZ Brussel
Department Name
Medische Oncologie
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
Site Name
CHC MontLegia
Department Name
Département d'Oncologie/Hématologie
Contact Person Name
Gauthier Demolin
Contact Person Email
GAUTHIER.DEMOLIN@CHC.BE

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Marketing authorisation (EU/1/18/1322/001)
Maximum Dose
1500 mg
Investigational Product Name
The Placebo is formulated as 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
Modality
Other
Authorisation Status
Not applicable
Combination Treatment
Yes

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