Clinical Trials /

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

NCT04770896

Description:

This is a Phase III, open label, randomized, two-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone in locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) participants who have progressed following prior HCC treatment with atezolizumab and bevacizumab combination.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
  • Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

Clinical Trial IDs

  • ORG STUDY ID: MO42541
  • NCT ID: NCT04770896

Conditions

  • Unresectable Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
AtezolizumabTecentriqAtezolizumab + Lenvatinib or Sorafenib
LenvatinibAtezolizumab + Lenvatinib or Sorafenib
SorafenibAtezolizumab + Lenvatinib or Sorafenib

Purpose

This is a Phase III, open label, randomized, two-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone in locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) participants who have progressed following prior HCC treatment with atezolizumab and bevacizumab combination.

Trial Arms

NameTypeDescriptionInterventions
Atezolizumab + Lenvatinib or SorafenibExperimentalParticipants will receive atezolizumab plus lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Atezolizumab
  • Lenvatinib
  • Sorafenib
Lenvatinib or SorafenibActive ComparatorParticipants will receive lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Lenvatinib
  • Sorafenib

Eligibility Criteria

        Inclusion Criteria:

          -  Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by
             histology/ cytology or clinically by American Association for the Study of Liver
             Diseases (AASLD) criteria in cirrhotic patients.

          -  Disease progression following prior atezolizumab plus bevacizumab combination
             treatment for HCC, for at least 4 consecutive treatment cycles, or 2 subsequent tumor
             assessments, whichever is longer.

          -  At least one measurable (per RECIST v1.1) target lesion that has not been previously
             treated with local therapy or, if the target lesion is within the field of previous
             local therapy, has subsequently progressed in accordance with RECIST v1.1.

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7
             days prior to randomization

          -  Child-Pugh class A within 7 days prior to randomization

          -  Adequate hematologic and end-organ function

        Exclusion Criteria:

          -  Symptomatic, untreated, or actively progressing central nervous system (CNS)
             metastases.

          -  History of leptomeningeal disease

          -  History of hepatic encephalopathy, proceeding 6 months, unresponsive to therapy within
             3 days

          -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

          -  History of malignancy other than HCC within 5 years prior to screening, with the
             exception of malignancies with a negligible risk of metastasis or death
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Randomization until death from any cause (approximately 42 months)
Safety Issue:
Description:Overall survival (OS) is defined as the time from randomization into the study to death from any cause.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Randomization until the first occurrence of disease progression or death from any cause whichever occurs first (approximately 42 months)
Safety Issue:
Description:Progression free survival (PFS) is defined as the time from randomization into the study to the first occurrence of disease progression or death from any cause (whichever occurs first).
Measure:Confirmed Objective Response Rate (ORR)
Time Frame:Approximately 42 months
Safety Issue:
Description:Confirmed Objective Response Rate (ORR) is defined as the proportion of patients with a best response of either complete or partial response.
Measure:Time to Progression (TTP)
Time Frame:Randomization until the first occurrence of disease progression (approximately 42 months)
Safety Issue:
Description:Time to Progression (TTP) is defined as the time from randomization to the first occurrence of disease progression.
Measure:Duration of Response (DOR)
Time Frame:Time from the first occurrence of a confirmed documented objective response to disease progression or death from any cause whichever occurs first (approximately 42 months)
Safety Issue:
Description:Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed documented objective response to disease progression or death from any cause (whichever occurs first).
Measure:Time to deterioration (TTD)
Time Frame:Randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months)
Safety Issue:
Description:Time to deterioration (TTD) is defined as the time from randomization to first deterioration (decrease from baseline of ≥ 10 points) maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks (if Cycle 1-6) or 6 weeks (if after Cycle 6) in the following European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30(EORTC QLQC30) scales (separately): physical function, role function, and GHS/QoL.
Measure:Percentage of Participants With Adverse Events
Time Frame:Throughout study duration (approximately 42 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events for Combination Treatment, Adverse Events Related to Atezolizumab, and TKI-Related Adverse Events
Time Frame:Throughtout study (approximately 42 months)
Safety Issue:
Description:
Measure:Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame:Throughout study (approximately 42 months)
Safety Issue:
Description:
Measure:Serum Concentration of Atezolizumab
Time Frame:At pre-defined intervals from first administration of study drug to approximately 42 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

March 24, 2021