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Monoclonal Antibodies
RP3 + Atezolizumab + Bevacizumab for Liver Cancer
Phase 2
Waitlist Available
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening through 60 days after last dose of rp3, or 135 days after last dose of atezolizumab/bevacizumab
Awards & highlights
Study Summary
This trial tests a new combo therapy to treat advanced or metastatic liver cancer not treatable with surgery or other treatments.
Who is the study for?
Adults with advanced, inoperable or metastatic liver cancer (Hepatocellular Carcinoma) who have either not had systemic therapy or have tried one that includes anti-PD-1/PD-L1. They must be generally healthy, with proper kidney, blood and liver function, and no recent use of investigational drugs. Women of childbearing age need a negative pregnancy test and agree to contraception.Check my eligibility
What is being tested?
The trial is testing RP3 combined with atezolizumab plus bevacizumab as first- or second-line treatments for Hepatocellular Carcinoma. It's an open-label Phase 2 study where all participants know which treatment they're getting.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion responses similar to allergic reactions, fatigue, issues like nausea or diarrhea from the digestive system being upset, changes in blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening through 60 days after last dose of rp3, or 135 days after last dose of atezolizumab/bevacizumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through 60 days after last dose of rp3, or 135 days after last dose of atezolizumab/bevacizumab
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate per modified RECIST 1.1
Secondary outcome measures
Clinical Benefit Rate
Complete response rate
Duration of Clinical Benefit
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 2L:RP3 w/atezolizumab + bevacizumab in advanced HCC not amenable to locoregional thrpy after PD(L)1Experimental Treatment3 Interventions
RP3 will be injected by direct or image-guided injection into injectable tumors (eg,primary sitehepatic tumors, hepatic metastases, non-hepatic metastases, visceral, or nodal tumors).
Group II: 1L:RP3 w/atezolizumab + bevacizumab in advanced HCC not amenable to resection/locoregional therapiesExperimental Treatment3 Interventions
RP3 will be injected by direct or image-guided injection into injectable tumors (eg,primary sitehepatic tumors, hepatic metastases, non-hepatic metastases, visceral, or nodal tumors).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bevacizumab
2002
Completed Phase 3
~3360
atezolizumab
2016
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,736 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
642 Patients Enrolled for Hepatocellular Carcinoma
Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,275 Total Patients Enrolled
Jaroslaw Jac, MDStudy ChairReplimune Inc.
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to provide a recent or new tumor biopsy for the study.My liver cancer has been confirmed by tissue analysis.I have a history of serious heart problems.I am able to understand and sign the consent form.I am HIV positive.I haven't had cancer treatment in the last 4 weeks.I haven't taken high doses of steroids in the last 14 days.I have a tumor that is at least 1cm big, or a lymph node that is at least 1.5cm in its shortest dimension.I am on medication for an autoimmune disease.I have a history of lung diseases.I am fully active or can carry out light work.My liver disease is moderately to severely advanced.I have had recent bleeding from untreated or partially treated varices in my esophagus or stomach.I have not had any cancer active in the last 3 years.I am 18 years old or older.I have been diagnosed with hepatitis B or C.I agree to use birth control to prevent pregnancy during the trial.I have not received a live vaccine in the last 28 days.I cannot safely stop my blood thinner medication.I have an infection that is not responding to treatment.I am allergic to some medications or have had reactions to monoclonal antibody treatments.I have had an organ transplant.My liver cancer cannot be removed by surgery and has spread.I have a tumor that can be injected and is at least 1cm big.My liver tests are within the required range.My kidney function is within the normal range.My liver cancer affects more than one-third of my liver.My liver function is classified as Child-Pugh A.I haven't needed IV antibiotics for an infection in the last 14 days.My condition can be treated with surgery or local therapies.I have been treated with virus therapy for cancer.I have had liver-related brain or kidney issues that didn't improve with treatment.I have active tuberculosis.My cancer has spread into major blood vessels.My cancer has spread to my brain or the membranes around my brain and spinal cord.I haven't had major surgery in the last 28 days and don't plan any while on the study.I haven't taken any herbal treatments in the last 2 weeks.I have not had a major bleeding event in the past year.I have not had radiotherapy in the last 2 weeks.I have had fluid drained from around my lungs, heart, or abdomen within the last week.
Research Study Groups:
This trial has the following groups:- Group 1: 1L:RP3 w/atezolizumab + bevacizumab in advanced HCC not amenable to resection/locoregional therapies
- Group 2: 2L:RP3 w/atezolizumab + bevacizumab in advanced HCC not amenable to locoregional thrpy after PD(L)1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollments open for this experiment at the present time?
"Per the data present on clinicaltrials.gov, this research endeavour is not presently enrolling participants. The trial was initially posted June 1st 2023 and last modified April 13th 2023; however, 2630 different trials are currently open for enrolment."
Answered by AI
In what number of healthcare facilities is this trial being conducted?
"Many places are accommodating participants for this trial, such as the Roswell Park Comprehensive Cancer Center in Buffalo, University of Cincinnati in Cincinnati and University of Pennsylvania Abramson Cancer Center in Philadelphia. In total there are 7 research sites available."
Answered by AI
Is the combination of 2L:RP3, atezolizumab and bevacizumab for advanced hepatocellular carcinoma not suitable for local therapy after PD(L)1 given FDA approval?
"Our team's assessment of the safety of 2L:RP3 w/atezolizumab + bevacizumab in advanced HCC not amenable to locoregional thrpy after PD(L)1 is 2 on a scale from 1-3, as this is only Phase 2 and there has been limited data collected regarding efficacy."
Answered by AI
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