Clinical trial • Phase III • Oncology
DURVALUMAB for Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma
Phase III trial of DURVALUMAB for Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 05-04-2024
- First CTIS Authorization Date
- 05-06-2024
Trial design
Randomised, placebo plus gemcitabine/cisplatin (arm b) versus durvalumab plus gemcitabine/cisplatin (arm a); specific doses and schedules not specified in the provided record-controlled Phase III trial in Poland, Italy, France and others.
- Randomised
- Yes
- Comparator
- Placebo plus gemcitabine/cisplatin (Arm B) versus Durvalumab plus gemcitabine/cisplatin (Arm A); specific doses and schedules not specified in the provided record
- Target Sample Size
- 685
Eligibility
Recruits 685 Vulnerable population not selected (isVulnerablePopulationSelected=false). Consent expected from adult participants only; no vulnerable/paediatric population indicated in record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Consent expected from adult participants only; no vulnerable/paediatric population indicated in record.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma."}
- {"criterion_text":"- Previously untreated disease if unresectable or metastatic at initial diagnosis"}
- {"criterion_text":"- Recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation)"}
- {"criterion_text":"- WHO/ECOG PS of 0 or 1"}
Exclusion criteria
- {"criterion_text":"- History of another primary malignancy"}
- {"criterion_text":"- Brain metastases or spinal cord compression"}
- {"criterion_text":"- Uncontrolled intercurrent illness"}
- {"criterion_text":"- Major surgical procedure within 28 days prior to the first dose of IP."}
- {"criterion_text":"- Prior locoregional therapy such as radioembolization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) according to RECIST 1.1using Investigator assessments","definition_or_measurement_approach":"According to RECIST 1.1 using Investigator assessments (as stated)"}
- {"endpoint_text":"- ORR and DoR according to RECIST 1.1 using BICR assessments","definition_or_measurement_approach":"According to RECIST 1.1 using Blinded Independent Central Review (BICR) (as stated)"}
- {"endpoint_text":"- EORTC QLQ-C30: Global health status/QoL and impacts (eg, physical function); multi-term symptoms (eg, fatigue); and single items (eg, appetite loss, insomnia). EORTC QLQ-BIL21: Single-item symptoms (eg, abdominal pain [item 42], pruritus [item 36], jaundice [item 35])","definition_or_measurement_approach":"Patient-reported outcomes using EORTC QLQ-C30 and EORTC QLQ-BIL21 instruments (as stated)"}
- {"endpoint_text":"- Association of PD-L1 expression level with PFS, ORR, DoR, and DCR (Disease control rate) according to RECIST 1.1 using Investigator assessments and OS (Overall survival)","definition_or_measurement_approach":"Subgroup analyses by PD-L1 expression level; endpoints assessed per RECIST 1.1 and OS (as stated)"}
- {"endpoint_text":"- Serum concentration of durvalumab (peak and trough concentrations)","definition_or_measurement_approach":"Pharmacokinetic measurements: serum peak and trough concentrations (as stated)"}
- {"endpoint_text":"- Presence of ADAs for durvalumab (confirmatory results: positive or negative)","definition_or_measurement_approach":"Immunogenicity testing for anti-drug antibodies (ADA) with confirmatory positive/negative results (as stated)"}
Recruitment
- Planned Sample Size
- 685
- Recruitment Window Months
- 11
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms available (country/language-specific documents present in record, e.g. 'L1_ SIS and ICF Main _Redacted_EU CTR', 'L1_ SIS and ICF Adult PL_Redacted', and other country-specific SIS/ICF documents). No paediatric assent process indicated.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 125
Poland
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 18-12-2024
- Processing Time Days
- 244
- Number Of Sites
- 2
- Number Of Participants
- 34
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Contact Person Name
- Renata Zaucha
- Contact Person Email
- rzaucha@gumed.edu.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddzial Chemioterapii Nowotworów z Pododzialem Nowotworow Jednego Dnia
- Contact Person Name
- Rafał Czyżykowski
- Contact Person Email
- rafal.czyzykowski@wp.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 16-12-2024
- Processing Time Days
- 242
- Number Of Sites
- 4
- Number Of Participants
- 31
Sites
- Site Name
- Careggi University Hospital
- Department Name
- Oncologia Medica
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@unifi.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Oncologia Medica
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@univr.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncologia
- Contact Person Name
- Stefano Tamberi
- Contact Person Email
- ste.tamberi@gmail.com
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Struttura Complessa di Oncologia Medica Addominale
- Contact Person Name
- Antonio Avallone
- Contact Person Email
- a.avallone@istitutotumori.na.it
France
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 17-12-2024
- Processing Time Days
- 243
- Number Of Sites
- 7
- Number Of Participants
- 47
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- department of digestive oncology
- Contact Person Name
- Marie Lequoy
- Contact Person Email
- marie.lequoy@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- department of digestive oncology
- Contact Person Name
- Eric Assenat
- Contact Person Email
- e-assenat@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- department of digestive oncology
- Contact Person Name
- David Tougeron
- Contact Person Email
- david.tougeron@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- department of digestive oncology
- Contact Person Name
- Sylvain Manfredi
- Contact Person Email
- sylvain.manfredi@chu-dijon.fr
- Site Name
- Hopital Beaujon
- Department Name
- department of digestive oncology
- Contact Person Name
- Mohamed Bouattour
- Contact Person Email
- Mohamed.bouattour@bjn.aphp.fr
- Site Name
- University Hospital Of Bordeaux
- Department Name
- oncology / digestive consultations
- Contact Person Name
- Jean-Frédéric Blanc
- Contact Person Email
- jean-frederic.blanc@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De ??? (duplicate entry details in record)
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 301
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Medical Center Nadezhda Clinikal EOOD
- Department Name
- Clinic of medical oncology
- Contact Person Name
- Mila Petrova
- Contact Person Email
- milllapetrova@gmail.com
- Site Name
- Acibadem City Clinic Tokuda University Hospital EAD
- Department Name
- Department of medical oncology
- Contact Person Name
- Jeliazko Arabadjiev
- Contact Person Email
- tcrc@acibademcityclinic.bg
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
- Authorised (EU/1/18/1322/001)
- Maximum Dose
- 1500 mg
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Investigational Product Name
- MYCOPHENOLATE MOFETIL
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- INFLIXIMAB
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Combination Treatment
- Yes
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