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Monoclonal Antibodies

Atezolizumab + Lenvatinib/Sorafenib for Liver Cancer (IMbrave251 Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

IMbrave251 Trial Summary

This trial is testing if adding atezolizumab to lenvatinib or sorafenib improves treatment of liver cancer that has progressed despite treatment with atezolizumab and bevacizumab.

Who is the study for?

This trial is for adults with advanced liver cancer who've seen their disease progress after treatment with Atezolizumab and Bevacizumab. They should have a good performance status, meaning they're able to carry out daily activities with minimal assistance. Patients must not have certain other cancers or brain metastases that are causing symptoms or require treatment.Check my eligibility

What is being tested?

The study compares the effectiveness of adding Atezolizumab to Lenvatinib or Sorafenib versus using Lenvatinib or Sorafenib alone in patients whose liver cancer has worsened despite previous treatments. It's a Phase III trial, which means it's testing a treatment already shown to be safe and effective in earlier phases.See study design

What are the potential side effects?

Atezolizumab can cause immune-related side effects like rash, hepatitis, colitis (inflammation of the colon), hormone gland problems, and infusion reactions. Lenvatinib and Sorafenib may cause high blood pressure, fatigue, diarrhea, appetite loss, weight loss, bleeding complications among others.

IMbrave251 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancer lesion that can be measured and has either not been treated or has grown after treatment.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My liver cancer is advanced, can't be removed by surgery, and is confirmed by tests or clinical criteria.

Select...

My liver cancer progressed after treatment with atezolizumab and bevacizumab.

IMbrave251 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Confirmed Objective Response Rate (ORR)

Duration of Response (DOR)

Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

+6 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

IMbrave251 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + Lenvatinib or SorafenibExperimental Treatment3 Interventions

Participants will receive atezolizumab plus lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group II: Lenvatinib or SorafenibActive Control2 Interventions

Participants will receive lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Lenvatinib

2005

Completed Phase 4

~2690

Sorafenib

2014

Completed Phase 3

~1670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,089,514 Total Patients Enrolled

4 Trials studying Liver Cancer

156 Patients Enrolled for Liver Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,386 Total Patients Enrolled

3 Trials studying Liver Cancer

126 Patients Enrolled for Liver Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04770896 — Phase 3

Liver Cancer Research Study Groups: Atezolizumab + Lenvatinib or Sorafenib, Lenvatinib or Sorafenib

Liver Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04770896 — Phase 3

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770896 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled patient positions in this clinical trial?

"Indeed, the clinical trial is recruiting patients at this time. The original posting was on 4/26/2021, and it has been updated as recently as 10/23/2022. There are 554 total patients that need to be enrolled from 4 different locations."

Answered by AI

What was the FDA's final determination on Atezolizumab?

"Atezolizumab's safety is well-documented, as this medication has moved through Phase 3 clinical trials. Our team rates it a 3 on a scale of 1 to 3."

Answered by AI

What are some other examples of research that has been conducted utilizing Atezolizumab?

"Atezolizumab was first studied in 2005 by Central Illinois Hematology Oncology Center. So far, 526 trials have been completed with 566 active trials presently underway globally; a significant number of these are in Calgary, Alberta."

Answered by AI

Where are the sites of this clinical trial?

"The following locations are running this study: Tom Baker Cancer Centre-Calgary in Calgary, Princess Margaret Cancer Center in Toronto, Juravinski Cancer Centre in Hamilton. Additionally, there are 4 other sites hosting this trial."

Answered by AI

Could I be a part of this experiment?

"In order to participate in this trial, individuals must be aged 18-75 and have a carcinoma diagnosis. In addition, potential participants must meet the following requirements: There must be at least one measurable target lesion that has not responded to local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed; The individual's cancer must be locally advanced or metastatic and/or unresectable with a HCC diagnosis confirmed by histology/ cytology or clinically by AASLD criteria in cirrhotic patients; There must be disease progression following prior atezolizumab plus bev"

Answered by AI

How many subjects are enrolled in this clinical trial?

"A total of 554 patients are needed to enroll in this clinical trial, and they must meet the specified inclusion criteria. These participants can come from various locations such as Tom Baker Cancer Centre-Calgary in Calgary, Alberta or Princess Margaret Cancer Center in Toronto, Ontario."

Answered by AI

Will this clinical trial be restricted to senior citizens?

"People who meet the age criteria of 18-75 years old can participate in this trial. Out of 4,422 total clinical trials, 112 are for people younger than 18 and 3,210 are for seniors."

Answered by AI

For what purpose is Atezolizumab primarily administered?

"Atezolizumab is a medication used to treat different conditions like small cell lung cancer (sclc) and malignant neoplasms. It can also be given as part of pharmacotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770896.

All > Hcc > Hepatocellular Carcinoma