Back to resultsA Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
Primary Purpose
Biliary Tract Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Bevacizumab
Placebo
Cisplatin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
Eligibility Criteria
Inclusion Criteria:
- Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
- Documentation of recurrent/metastatic or locally advanced unresectable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
- Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC
- No prior systemic therapy for advanced BTC
- At least one measurable untreated lesion (per RECIST v1.1)
- Adequate biliary drainage with no evidence of ongoing infection
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of > 3 months
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
- Recurrent disease <=6 months after curative surgery or <= 6 months after the completion of adjuvant therapy
- Prior local regional therapy such as radioembolization
- Combined or mixed hepatocellular/cholangiocarcinoma
- Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1
- National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade >= 2 peripheral neuropathy
- Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Symptomatic, untreated, or actively progressing CNS metastases
- For patients with lung metastases, if one of the following criteria applies: Large, centrally located pulmonary metastases; Clear tumor infiltration into the thoracic great vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging
- Active tuberculosis
- Co-infection with HBV and HCV
- Treatment with systemic immunostimulatory agents or immunosuppressive medication
- Inadequately controlled arterial hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease
- Evidence of bleeding diathesis or significant coagulopathy
- Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
- Preexisting renal impairment, myelosuppression, or hearing impairment
Sites / Locations
- City of Hope Cancer Center
- Massachusetts General Hospital
- Duke Cancer Center
- SCRI-Tennessee Oncology
- University of Virginia
- Nanfang Hospital, Southern Medical University
- Sir Run Run Shaw Hospital Zhejiang University
- Zhongshan Hospital Fudan University
- Queen Mary Hospital; Dept. Of Haematology & Oncology
- Prince of Wales Hosp; Dept. Of Clinical Onc
- Fondazione Pascale; U.O. Sperimentazioni Cliniche
- Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
- Istituto Clinico Humanitas - Humanitas Cancer Center
- IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
- CHA Bundang Medical Center
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
- Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
- NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
- Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
- FSBI "National Medical Research Center of Oncology N.N. Blokhin?
- First Moscow State Medical University n.a. I.M. Sechenov
- SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
- Complejo Hospitalario de Navarra; Servicio de Oncologia
- Hospital Universitari Vall d'Hebron; Oncology
- Hospital Ramon y Cajal; Servicio de Oncologia
- Complejo Hospitalario de Orense; Servicio de Oncologia
- Hospital Universitario Miguel Servet; Servicio Oncologia
- Taipei Veterans General Hospital; Department of Oncology
- National Taiwan Uni Hospital; Dept of Oncology
- Maharaj Nakorn Chiang Mai Hosp; Oncology Unit
- Srinagarind Hospital; Medical Oncology Unit
- Sunpasitthiprasong Hospital; Oncology and/or Hematology
- Adana Ac?badem Hospital Oncology Department
- Memorial Ankara Hastanesi
- Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
- Koc Universitesi Hastanesi; T?bbi Onkoloji
- SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
- ?Kharkov Regional Oncology Center
- SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine
- Beatson West of Scotland Cancer Centre
- Royal Free Hospital
- Churchill Hospital
- Royal Marsden Hospital (Sutton)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev
Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
Arm Description
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first).
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1
Time to Confirmed Deterioration (TTCD)
TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks.
Percentage of Participants With Adverse Events
Serum Concentration of Atezolizumab
Serum concentration of atezolizumab at specified timepoints.
Prevalence of ADAs to Atezolizumab
Incidence of ADAs to Atezolizumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04677504
Brief Title
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
Official Title
A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Arm Title
Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
Arm Type
Active Comparator
Arm Description
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab will be administered at a dose of 15 mg/kg intravenously on Day 1 of each 21-day cycle after atezolizumab.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matching bevacizumab will be administered intravenously on Day 1 of each 21-day cycle after atezolizumab.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered intravenously at a dose of 25 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered intravenously at a dose of 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)
Time Frame
Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Randomization to death from any cause (up to approximately 3-5 years)
Title
Confirmed Objective Response Rate (ORR)
Description
Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
Time Frame
Randomization up to approximately 14 months
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first).
Time Frame
First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months)
Title
Disease Control Rate (DCR)
Description
DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1
Time Frame
Randomization up to approximately 14 months
Title
Time to Confirmed Deterioration (TTCD)
Description
TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks.
Time Frame
Randomization to the first clinically meaningful deterioration (up to approximately 14 months)
Title
Percentage of Participants With Adverse Events
Time Frame
Randomization up to approximately 3-5 years
Title
Serum Concentration of Atezolizumab
Description
Serum concentration of atezolizumab at specified timepoints.
Time Frame
Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days)
Title
Prevalence of ADAs to Atezolizumab
Time Frame
Baseline
Title
Incidence of ADAs to Atezolizumab
Time Frame
At pre-defined intervals from administration of study drug up to approximately 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
Documentation of recurrent/metastatic or locally advanced unresectable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC
No prior systemic therapy for advanced BTC
At least one measurable untreated lesion (per RECIST v1.1)
Adequate biliary drainage with no evidence of ongoing infection
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of > 3 months
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
Recurrent disease <=6 months after curative surgery or <= 6 months after the completion of adjuvant therapy
Prior local regional therapy such as radioembolization
Combined or mixed hepatocellular/cholangiocarcinoma
Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1
National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade >= 2 peripheral neuropathy
Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Symptomatic, untreated, or actively progressing CNS metastases
For patients with lung metastases, if one of the following criteria applies: Large, centrally located pulmonary metastases; Clear tumor infiltration into the thoracic great vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging
Active tuberculosis
Co-infection with HBV and HCV
Treatment with systemic immunostimulatory agents or immunosuppressive medication
Inadequately controlled arterial hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease
Evidence of bleeding diathesis or significant coagulopathy
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Preexisting renal impairment, myelosuppression, or hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
SCRI-Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Queen Mary Hospital; Dept. Of Haematology & Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
Fondazione Pascale; U.O. Sperimentazioni Cliniche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Istituto Clinico Humanitas - Humanitas Cancer Center
City
Rozzano
State/Province
Sicilia
ZIP/Postal Code
20089
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Facility Name
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. I.M. Sechenov
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
City
Saint Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Complejo Hospitalario de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Complejo Hospitalario de Orense; Servicio de Oncologia
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Taipei Veterans General Hospital; Department of Oncology
City
Taipei City
ZIP/Postal Code
112201
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Maharaj Nakorn Chiang Mai Hosp; Oncology Unit
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital; Medical Oncology Unit
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Sunpasitthiprasong Hospital; Oncology and/or Hematology
City
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand
Facility Name
Adana Ac?badem Hospital Oncology Department
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Koc Universitesi Hastanesi; T?bbi Onkoloji
City
Zeyt?nburnu
ZIP/Postal Code
34010
Country
Turkey
Facility Name
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
?Kharkov Regional Oncology Center
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QS
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
34377158
Citation
Hack SP, Verret W, Mulla S, Liu B, Wang Y, Macarulla T, Ren Z, El-Khoueiry AB, Zhu AX. IMbrave 151: a randomized phase II trial of atezolizumab combined with bevacizumab and chemotherapy in patients with advanced biliary tract cancer. Ther Adv Med Oncol. 2021 Jul 31;13:17588359211036544. doi: 10.1177/17588359211036544. eCollection 2021.
Results Reference
derived
Learn more about this trial
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
We'll reach out to this number within 24 hrs