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Monoclonal Antibodies
Atezolizumab + Bevacizumab +/− SRF388 for Liver Cancer
Phase 2
Waitlist Available
Research Sponsored by Coherus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child-Pugh Class A disease
No prior systemic treatment for unresectable locally advanced or metastatic HCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug for liver cancer. The drug will be given with two other drugs to see if it is more effective than just giving the other two drugs.
Who is the study for?
Adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic treatment for their condition can join this trial. They should be in relatively good health, able to perform daily activities with ease or slight difficulty, and have a liver that's still working well. Pregnant women can't participate, and those who can have children must use birth control.Check my eligibility
What is being tested?
The study is testing the effectiveness of SRF388 combined with Atezolizumab and Bevacizumab versus a placebo mixed with the same two drugs in treating first-line advanced liver cancer. Participants are randomly assigned to one of these groups to compare results.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related responses, increased risk of infections due to weakened immunity, bleeding issues related to Bevacizumab, and general symptoms like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver disease is mild.
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I haven't had any treatments for my advanced liver cancer.
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I am 18 years old or older.
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My liver cancer cannot be removed by surgery and has spread.
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I am fully active or can carry out light work.
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My liver cancer is at an intermediate or advanced stage.
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I have taken a pregnancy test within the last week and it was negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Secondary outcome measures
Area under the serum concentration-time curve from time zero to the last quantifiable time point (AUC0-last)
Disease Control Rate (DCR)
Duration of Response (DoR) according to HCC mRECIST
+17 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Lead-InExperimental Treatment3 Interventions
A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.
Group II: Arm B: Placebo in combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions
Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.
Group III: Arm A: SRF388 in Combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions
Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Bevacizumab
FDA approved
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Coherus Biosciences, Inc.Lead Sponsor
11 Previous Clinical Trials
3,142 Total Patients Enrolled
Surface OncologyLead Sponsor
5 Previous Clinical Trials
555 Total Patients Enrolled
Vienna Reichert, PhDStudy ChairCoherus Biosciences, Inc.
1 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I frequently need procedures to remove excess fluid from my body.I am on or might need strong medication to suppress my immune system.I have an autoimmune disease or immune deficiency, but it's controlled or minor.My liver disease is mild.I have been treated with an anti-IL-27 therapy before.I have an active HIV infection.I haven't had any treatments for my advanced liver cancer.My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).I have brain metastases or leptomeningeal carcinomatosis that are not treated or causing symptoms.I am 18 years old or older.My liver cancer cannot be removed by surgery and has spread.I had treatment for cancer when it couldn't be removed by surgery, but it was over a year ago.I am fully active or can carry out light work.My liver cancer is at an intermediate or advanced stage.My high blood pressure is not well controlled.I have had or currently have brain function issues due to liver disease.I have moderate to severe fluid buildup in my abdomen.I have taken a pregnancy test within the last week and it was negative.I agree to use birth control or abstain from sex as required if I or my partner can become pregnant.I have varices at risk of bleeding that haven't been fully treated.I have hepatitis B or C, but it is under control or fully treated.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Placebo in combination with atezolizumab plus bevacizumab
- Group 2: Lead-In
- Group 3: Arm A: SRF388 in Combination with atezolizumab plus bevacizumab
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
How many individuals are being medicated as part of this research?
"Yes, as noted on the website clinicaltrials.gov, this study is still looking for patients to enroll. This trial was initially posted on April 12th, 2022 and has been updated as recently as August 15th, 2022. The goal is to have 134 people enrolled at 3 different locations."
Answered by AI
What is the primary aim of this clinical trial?
"The objective of this study, which will take place over a period of 2 years, is to track Progression Free Survival (PFS) in patients with solid tumors according to Response Evaluation Criteria in Solid Tumors (RECIST). Additionally, the study will measure Maximum observed serum concentration (Cmax) of SRF388 in order to assess Serum samples collected from participants. The study's secondary outcomes include Time to Progression (TTP) and Objective Response Rate (ORR), both according to RECIST v1.1."
Answered by AI
What are the potential risks associated with SRF388?
"SRF388 was given a safety rating of 2. This is because, although there is some data supporting its safety profile, none of it speaks to the medication's efficacy."
Answered by AI
Are we recruiting volunteers for this research right now?
"The clinical trial is still enrolling patients, according to the information available on clinicaltrials.gov. This study was originally posted on 4/12/2022 and was last updated on 8/15/2022. The researchers are looking for a total of 134 participants that will be drawn from 3 different locations."
Answered by AI
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