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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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04732286
Collaborator
(none)
100
Enrollment
27
Locations
1
Arm
28.7
Anticipated Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 4, 2021
Anticipated Primary Completion Date :
Mar 25, 2023
Anticipated Study Completion Date :
Sep 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (atezolizumab plus bevacizumab)

Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Drug: Atezolizumab
Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
Other Names:
  • Tecentriq

    • Drug: Bevacizumab
    Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
    Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Discontinuations of Atezolizumab and/or Bevacizumab Due to Adverse Events of Grade ≥ 3 [Initiation fo study treatment up to approximately 3 years]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Initiation of study treatment to death from any cause (up to approximately 3 years)]

      OS is defined as the time from initiation of study treatment to death from any cause.

    2. Severity of Adverse Events According to NCI CTCAE v5.0 [Initiation of study treatment up to approximately 3 years]

      The adverse event severity grading scale for the NCI CTCAE (v5.0) will be used for assessing adverse event severity.

    3. Progression Free Survival (PFS) [Initiation of study treatment to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 3 years)]

      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.

    4. Time to Progression (TTP) [Initiation of study treatment to first occurrence of disease progression (up to approximately 3 years)]

      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.

    5. Duration of Response (DOR) [Documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 3 years)]

      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.

    6. Number/Rate of Participants Starting Second Line Treatment [Up to approximately 3 years]

    7. International Normalized Ratio (INR) [Up to approximately 3 years]

    8. Presence of Absence of Ascites and/or Hepatic Encephalopathy [Up to approximately 3 years]

    9. Albumin-Bilirubin (ALBI) Assessment Grades of 1 to 3 [Up to approximately 3 years]

      Albumin-Bilirubin Assessment Grades of 1 to 3 based on ALBI score calculation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital General Universitario de Elche; Servicio de Oncologia Elche Alicante Spain 03203
    2 Hospital Univ. Central de Asturias; servicio de Digestivo Oviedo Asturias Spain 33011
    3 Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia Sabadell Barcelona Spain 08208
    4 Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Santander Cantabria Spain 39008
    5 Hospital Provincial de Castellon; Servicio de Oncologia Castellon de La Plana Castellon Spain 12002
    6 Hospital Son Llatzer; Servicio de Oncologia Palma de Mallorca Islas Baleares Spain 07198
    7 Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña Spain 15706
    8 Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo Las Palmas de Gran Canaria LAS Palmas Spain 35010
    9 Hospital Universitario de Torrejon; Servicio de Oncología Torrejón de Ardoz Madrid Spain 28850
    10 Clinica Universitaria de Navarra; Servicio de Hepatologia Pamplona/iruña Navarra Spain 31008
    11 Hospital de Basurto; Servicio de Oncologia Bilbao Vizcaya Spain 48013
    12 Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia Albacete Spain 02006
    13 Hospital General Univ. de Alicante; Servicio de Hepatologia Alicante Spain 03010
    14 Complejo Hospitalario Torrecardenas; Servicio de Hepatologia Almeria Spain 04009
    15 Hospital Universitari Vall d'Hebron; Servicio de Hepatologia Barcelona Spain 08035
    16 Hospital Clinic i Provincial; Servicio de Hepatología Barcelona Spain 08036
    17 Hospital Universitario Reina Sofia; Servicio de Hepatologia Cordoba Spain 14004
    18 Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen Spain 23007
    19 Hospital Lucus Augusti; Servicio de Oncologia Lugo Spain 27003
    20 Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo Madrid Spain 28007
    21 Clinica Universidad de Navarra Madrid; Servicio de Oncología Madrid Spain 28027
    22 Hospital Universitario Ramón y Cajal; Servicio de Digestivo Madrid Spain 28034
    23 Hospital Clinico San Carlos; Servicio de Oncologia Madrid Spain 28040
    24 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    25 Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia Sevilla Spain 41014
    26 Hospital Universitari i Politecnic La Fe; Oncologia Valencia Spain 46026
    27 Hospital Universitario Miguel Servet; Servicio Oncologia Zaragoza Spain 50009

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04732286
    Other Study ID Numbers:
    • ML42600
    First Posted:
    Feb 1, 2021
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Bevacizumab
    Atezolizumab

    Study Results

    No Results Posted as of Jun 16, 2022