Back to resultsA Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy
Primary Purpose
Carcinoma, Hepatocellular
Status
Active
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Atezolizumab
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion Criteria:
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically, following the AASLD criteria
- Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
- No prior systemic therapy (including systemic investigational agents) for HCC
- At least one measurable (per RECIST 1.1) untreated lesion detected by CT scan
- Patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1
Exclusion Criteria:
- 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 (CT) scan
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Co-infection of HBV and HCV
Sites / Locations
- Hospital General Universitario de Elche; Servicio de Oncologia
- Hospital Univ. Central de Asturias; servicio de Digestivo
- Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
- Hospital Provincial de Castellon; Servicio de Oncologia
- Hospital Son Llatzer; Servicio de Oncologia
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
- Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
- Hospital Universitario de Torrejon; Servicio de Oncología
- Clinica Universitaria de Navarra; Servicio de Hepatologia
- Hospital de Basurto; Servicio de Oncologia
- Hospital General Univ. de Alicante; Servicio de Hepatologia
- Complejo Hospitalario Torrecardenas; Servicio de Hepatologia
- Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
- Hospital Clinic i Provincial; Servicio de Hepatología
- Hospital Universitario Reina Sofia; Servicio de Hepatologia
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
- Hospital Lucus Augusti; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo
- Clinica Universidad de Navarra Madrid; Servicio de Oncología
- Hospital Universitario Ramón y Cajal; Servicio de Digestivo
- Hospital Clinico San Carlos; Servicio de Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
- Hospital Universitari i Politecnic La Fe; Oncologia
- Hospital Universitario Miguel Servet; Servicio Oncologia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A (atezolizumab plus bevacizumab)
Arm Description
Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Outcomes
Primary Outcome Measures
Incidence of Treatment Discontinuations of Atezolizumab and/or Bevacizumab Due to Adverse Events of Grade ≥ 3
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause.
Severity of Adverse Events According to NCI CTCAE v5.0
The adverse event severity grading scale for the NCI CTCAE (v5.0) will be used for assessing adverse event severity.
Progression Free Survival (PFS)
PFS is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time to Progression (TTP)
Time to progression (TTP) is defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria.
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Number/Rate of Participants Starting Second Line Treatment
International Normalized Ratio (INR)
Presence of Absence of Ascites and/or Hepatic Encephalopathy
Albumin-Bilirubin (ALBI) Assessment Grades of 1 to 3
Albumin-Bilirubin Assessment Grades of 1 to 3 based on ALBI score calculation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04732286
Brief Title
A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy
Official Title
A Phase IIIb, Single Arm, Multicenter Study of Atezolizumab in Combination With Bevacizumab to Investigate Safety and Efficacy in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
April 27, 2024 (Anticipated)
Study Completion Date
April 27, 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (atezolizumab plus bevacizumab)
Arm Type
Experimental
Arm Description
Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered intravenously at a 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 by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Incidence of Treatment Discontinuations of Atezolizumab and/or Bevacizumab Due to Adverse Events of Grade ≥ 3
Time Frame
Initiation fo study treatment up to approximately 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from initiation of study treatment to death from any cause.
Time Frame
Initiation of study treatment to death from any cause (up to approximately 3 years)
Title
Severity of Adverse Events According to NCI CTCAE v5.0
Description
The adverse event severity grading scale for the NCI CTCAE (v5.0) will be used for assessing adverse event severity.
Time Frame
Initiation of study treatment up to approximately 3 years
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time Frame
Initiation of study treatment to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 3 years)
Title
Time to Progression (TTP)
Description
Time to progression (TTP) is defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria.
Time Frame
Initiation of study treatment to first occurrence of disease progression (up to approximately 3 years)
Title
Duration of Response (DOR)
Description
Duration of Response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time Frame
Documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 3 years)
Title
Number/Rate of Participants Starting Second Line Treatment
Time Frame
Up to approximately 3 years
Title
International Normalized Ratio (INR)
Time Frame
Up to approximately 3 years
Title
Presence of Absence of Ascites and/or Hepatic Encephalopathy
Time Frame
Up to approximately 3 years
Title
Albumin-Bilirubin (ALBI) Assessment Grades of 1 to 3
Description
Albumin-Bilirubin Assessment Grades of 1 to 3 based on ALBI score calculation.
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically, following the AASLD criteria
Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
No prior systemic therapy (including systemic investigational agents) for HCC
At least one measurable (per RECIST 1.1) untreated lesion detected by CT scan
Patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1
Exclusion Criteria:
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 (CT) scan
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Co-infection of HBV and HCV
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
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Univ. Central de Asturias; servicio de Digestivo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario de Torrejon; Servicio de Oncología
City
Torrejón de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Hepatologia
City
Pamplona/iruña
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de Basurto; Servicio de Oncologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital General Univ. de Alicante; Servicio de Hepatologia
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Complejo Hospitalario Torrecardenas; Servicio de Hepatologia
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Hepatología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Hepatologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Lucus Augusti; Servicio de Oncologia
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Clinica Universidad de Navarra Madrid; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal; Servicio de Digestivo
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe; Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
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).
Learn more about this trial
A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy
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