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Trial record 1 of 1 for:    ML42600
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732286
Recruitment Status : Active, not recruiting
First Posted : February 1, 2021
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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
Carcinoma, Hepatocellular Drug: Atezolizumab Drug: Bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : October 27, 2023
Estimated Study Completion Date : October 27, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Overall Survival (OS) [ Time Frame: 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 [ Time Frame: 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) [ 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) ]
    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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to approximately 3 years ]
  7. International Normalized Ratio (INR) [ Time Frame: Up to approximately 3 years ]
  8. Presence of Absence of Ascites and/or Hepatic Encephalopathy [ Time Frame: Up to approximately 3 years ]
  9. Albumin-Bilirubin (ALBI) Assessment Grades of 1 to 3 [ Time Frame: Up to approximately 3 years ]
    Albumin-Bilirubin Assessment Grades of 1 to 3 based on ALBI score calculation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732286


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04732286    
Other Study ID Numbers: ML42600
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Bevacizumab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors