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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
Select...
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 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
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Musculoskeletal chest pain
1%
Respiratory tract infection
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,090,838 Total Patients Enrolled
4 Trials studying Liver Cancer
156 Patients Enrolled for Liver Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,482 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
~42 spots leftby Sep 2024
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