Trial Title:
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
NCT ID:
NCT05771480
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Paclitaxel
Cisplatin
Carboplatin
Gemcitabine
Oxaliplatin
Durvalumab
Albumin-Bound Paclitaxel
Conditions: Keywords:
monoclonal antibodies
PD-L1 antagonist
Durvalumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a single arm study with durvalumab in combination with investigator's choice of 7
different background gemcitabine-based chemotherapy regimens in participants with aBTC.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Durvalumab
Description:
Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with
chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of
chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as
monotherapy)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Intervention type:
Drug
Intervention name:
Gemcitabine monotherapy
Description:
Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e.,
8 cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Intervention type:
Drug
Intervention name:
Gemcitabine + cisplatin
Description:
Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks
(i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Intervention type:
Drug
Intervention name:
Gemcitabine + oxaliplatin
Description:
Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks
(i.e., 8 cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Intervention type:
Drug
Intervention name:
Gemcitabine + carboplatin
Description:
Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks
(i.e., 8 cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Intervention type:
Drug
Intervention name:
Gemcitabine + cisplatin + S-1
Description:
Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks
(i.e, 4 cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen.
Other name:
This regimen is not allowed for countries in the European Union.
Intervention type:
Drug
Intervention name:
Gemcitabine + S-1
Description:
Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8
cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background Gemcitabine-based Chemotherapy Regimen
Other name:
This regimen is not allowed for countries in the European Union.
Intervention type:
Drug
Intervention name:
Gemcitabine + cisplatin + albumin-bound paclitaxel
Description:
Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based
chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Arm group label:
Durvalumab + Gemcitabine based chemotherapy
Other name:
Background gemcitabine-based chemotherapy Regimen
Other name:
This regimen is not allowed for countries in the European Union.
Summary:
A study to assess the safety and efficacy of durvalumab in combination with
gemcitabine-based chemotherapy regimens in participants with aBTC.
Detailed description:
This study involves assessing the safety and efficacy of durvalumab in combination with
different gemcitabine-based chemotherapy regimens as first line therapy for aBTC. The
target population of interest in this study is participants with aBTC who are ≥ 18 years
of age and above legal age per local regulations with WHO/ECOG PS of 0 to 2 at enrolment
and who are not eligible for locoregional therapy. Participants with WHO/ECOG PS 2 will
be capped at 20% of the overall treated participant population.
The study consists of 4 periods: screening period (Day-28 to Day -1), treatment period up
to 8 cycles of gemcitabine-based chemotherapy regimens with durvalumab, maintenance
treatment with durvalumab alone or in combination with gemcitabine-based chemotherapy
(with the exception of paclitaxel), and then safety and survival follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed, unresectable advanced or metastatic biliary tract
carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic),
gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
- Participants with unresectable or metastatic BTC
- A World Health Organisation Eastern Cooperative Oncology Group Performance Status
(WHO/ECOG PS) of 0 to 2
- At least one lesion that qualifies as a Response Evaluation Criteria in Solid
Tumours version 1.1 (RECIST 1.1) target lesion at baseline
- Adequate organ and bone marrow function
- Body weight of > 30 kg
- Negative pregnancy test (serum) for women of childbearing potential
- Female participants must be one year post-menopausal (amenorrhoeic for 12 months
without an alternative medical cause)
- Male and female participants and their partners must be surgically sterile or on
their chosen method of birth control as per the protocol.
Exclusion Criteria:
- Any evidence of diseases such as severe or uncontrolled systemic diseases, including
uncontrolled hypertension, active bleeding diseases, active infection, active
interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions
associated with diarrhoea, psychiatric illness/social situations, history of
uncontrolled or symptomatic cardiac disease, and history of allogenic organ
transplant
- Active or prior documented autoimmune or inflammatory disorders
- History of another primary malignancy, except for malignancy treated with curative
intent and with no known active disease ≥ 5 years before the first dose of study
intervention
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Known to have tested positive for human immunodeficiency virus [HIV] (positive HIV
1/2 antibodies) or active tuberculosis infection
- Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or
co-infected with HBV and Hepatitis D virus (HDV)
- Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade
> 1) caused by previous anticancer therapy
- Central nervous system metastases requiring treatment or history of spinal cord
compression
- Known allergy or hypersensitivity to any of the study intervention or any of the
study intervention excipients.
- Any concurrent chemotherapy, other than the one allowed in the study,
investigational medicinal product (IMP), biologic, or hormonal therapy for cancer
treatment
- Palliative radiotherapy with a limited field of radiation within 2 weeks of the
first dose of study intervention, or radiotherapy with a wide field of radiation or
radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the
first dose of study intervention
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study
intervention
- Major surgical procedure within 28 days prior to the first dose of IMP
- Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
- Receipt of the last dose of anticancer therapy within 28 days prior to the first
dose of IMP
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Mobile
Zip:
36607
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Oklahoma City
Zip:
73142
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Clichy
Zip:
92110
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lyon Cedex 03
Zip:
69437
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montpellier Cedex 5
Zip:
34090
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chemnitz
Zip:
09131
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Freudenstadt
Zip:
72250
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Muenchen
Zip:
81377
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Castelfranco Veneto
Zip:
31033
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Foggia
Zip:
71122
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kanazawa-shi
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
227-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kyoto
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ube
Zip:
755-8505
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wakayama
Zip:
641-8509
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
258499
Country:
Singapore
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
329563
Country:
Singapore
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Start date:
August 16, 2023
Completion date:
March 17, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771480
