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Immunotherapy
Immunotherapy Combinations for Advanced Liver Cancer
Phase 1 & 2
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
Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients
Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 5-7 years)
Awards & highlights
Study Summary
This trial is designed to study new treatments for advanced liver cancer. It is open-label, meaning that participants and researchers will know which treatment is being received, and it is multicenter, meaning that it will be conducted at multiple research sites. The trial is also randomized, meaning that participants will be assigned to different treatment groups by chance.
Who is the study for?
Adults with advanced liver cancer (HCC) who haven't had systemic therapy can join this trial. They must have measurable disease, proper organ function, and no HIV or active hepatitis. Participants need to agree to use contraception and should not have a history of certain medical conditions like severe allergies or autoimmune diseases.Check my eligibility
What is being tested?
The study tests multiple immunotherapy combinations including RO7247669 at different doses, Bevacizumab, ADG126, Atezolizumab, Tiragolumab, Tocilizumab, TPST-1120 for effectiveness and safety in treating liver cancer. It's flexible to adapt as new treatments emerge or existing ones show minimal benefit or high toxicity.See study design
What are the potential side effects?
Potential side effects include immune reactions that may cause inflammation in organs like the liver or lungs; infusion-related reactions; fatigue; blood disorders; increased risk of infections; digestive issues such as nausea and diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer cannot be removed by surgery and is confirmed by tests or clinical criteria.
Select...
My blood and organ functions are within normal ranges as of last week.
Select...
I have not received any systemic treatment for liver cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My condition cannot be cured with surgery or local treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 5-7 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 5-7 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Disease Control
Duration of Response (DOR)
OS at Specific Timepoints
+4 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Stage 1: RO7247669 600 mg Q3W + BevacizumabExperimental Treatment2 Interventions
Participants will receive RO7247669 plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group II: Stage 1: RO7247669 2100 mg Q2W + BevacizumabExperimental Treatment2 Interventions
Participants will receive RO7247669 plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group III: Stage 1: RO7247669 1200 mg Q3W + BevacizumabExperimental Treatment2 Interventions
Participants will receive RO7247669 plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group IV: Stage 1: Atezolizumab + Bevacizumab + TocilizumabExperimental Treatment3 Interventions
Participants will receive atezolizumab plus bevacizumab plus tocilizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group V: Stage 1: Atezolizumab + Bevacizumab + TiragolumabExperimental Treatment3 Interventions
Participants will receive atezolizumab plus bevacizumab plus tiragolumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group VI: Stage 1: Atezolizumab + Bevacizumab + TPST-1120Experimental Treatment3 Interventions
Participants will receive atezolizumab plus bevacizumab plus TPST-1120 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group VII: Stage 1: Atezolizumab + Bevacizumab + ADG126Experimental Treatment3 Interventions
Participants will receive atezolizumab plus bevacizumab plus ADG126 until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Group VIII: Stage 1: Atezolizumab + BevacizumabActive Control2 Interventions
Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,580 Total Patients Enrolled
2 Trials studying Liver Cancer
37 Patients Enrolled for Liver Cancer
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,022 Total Patients Enrolled
4 Trials studying Liver Cancer
156 Patients Enrolled for Liver Cancer
Adagene IncIndustry Sponsor
10 Previous Clinical Trials
541 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had episodes of brain confusion due to liver problems.My cancer is in the early stages (Stage 1 or 2).I've had liver therapy within the last 28 days or am still experiencing side effects.I have not coughed up blood in the last month.I have serious blood vessel problems.I have moderate to severe fluid buildup in my abdomen.My cancer has spread to major airways or blood vessels.I have a serious wound, ulcer, or untreated bone fracture that is not healing.My side effects from cancer treatment are mild, except for hair loss.I have had a severe hypertension crisis or brain issues due to high blood pressure.I take NSAID medication every day for a chronic condition.I had bleeding from esophageal or stomach varices in the last 6 months.My cancer is in an early stage (1 or 2).I haven't had major heart problems or unstable heart conditions in the last 3 months.You have experienced severe allergic reactions to certain types of medications called chimeric or humanized antibodies or fusion proteins.I have not had any cancer other than liver cancer in the last 5 years.I am not allergic to the study drugs and haven't taken any immune-modifying drugs recently.I have side effects from immunotherapy that haven't improved to mild or returned to normal.A sample of my tumor is available from a recent biopsy.I haven't taken any immune-weakening drugs in the last 2 weeks.My cancer is in the early stage (Stage 1).I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after treatment.My liver cancer is a specific type (Fibrolamellar, sarcomatoid, or mixed).My liver cancer cannot be removed by surgery and is confirmed by tests or clinical criteria.I haven't had major surgery or serious injuries recently.I have pain from my cancer that isn't relieved by treatment.My blood and organ functions are within normal ranges as of last week.You have a current or past autoimmune disease or a weakened immune system.I have not received any systemic treatment for liver cancer.My liver function is classified as Child-Pugh A.I am fully active or restricted in physically strenuous activity but can do light work.I can start Stage 2 treatment within 3 months if Stage 1 causes side effects not from atezolizumab or RO7247669, or stops working.I am currently taking or have recently taken high-dose aspirin or certain blood thinners.I haven't had radiotherapy recently, except for bone lesion treatment last week.I have had inflammation in my abdomen before.I have had cancer spread to the lining of my brain and spinal cord.I haven't had major surgery in the last 4 weeks and don't expect any during the study.I have not had a severe infection in the last 4 weeks.I have untreated or partially treated varices in my esophagus or stomach that are bleeding or likely to bleed.I have not taken any strong antibiotics in the last 2 weeks.I have previously been treated with immune system boosting drugs.I have active tuberculosis.I have moderate to severe protein in my urine.I have high calcium levels in my blood that are causing symptoms.I am currently using or have recently used blood thinners for treatment.I had a biopsy or minor surgery within the last 3 days.I can take care of myself and am up and about more than half of my waking hours.I have had lung conditions like IPF or pneumonia, or signs of these on a chest CT scan.I can provide a sample of my tumor for PD-L1 and other tests.I have had a stem cell or organ transplant in the past.My high blood pressure is not well-controlled.I have brain metastases that are causing symptoms or getting worse.I have had serious stomach or throat complications.I frequently need procedures to remove excess fluid from my chest or abdomen.My cancer is at stage 2.You have taken experimental medication within the past 28 days before starting this study.My condition cannot be cured with surgery or local treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1: Atezolizumab + Bevacizumab + ADG126
- Group 2: Stage 1: Atezolizumab + Bevacizumab + TPST-1120
- Group 3: Stage 1: RO7247669 2100 mg Q2W + Bevacizumab
- Group 4: Stage 1: RO7247669 600 mg Q3W + Bevacizumab
- Group 5: Stage 1: RO7247669 1200 mg Q3W + Bevacizumab
- Group 6: Stage 1: Atezolizumab + Bevacizumab
- Group 7: Stage 1: Atezolizumab + Bevacizumab + Tiragolumab
- Group 8: Stage 1: Atezolizumab + Bevacizumab + Tocilizumab
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.
Liver Cancer Patient Testimony for trial: Trial Name: NCT04524871 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic purposes is RO7247669 typically employed for?
"RO7247669 is a commonly used medication for recurrent platinum-resistant epithelial ovarian cancer. This drug may also be beneficial when treating systemic juvenile idiopathic arthritis (sjia), malignant neoplasms, and recurrent platinum sensitive primary peritoneal cancer."
Answered by AI
To what extent has RO7247669 been examined in earlier research?
"Presently, 681 clinical trials are underway in order to explore the effects of RO7247669. Of those studies, 150 have progressed beyond Phase 2 and into the third phase of research. Although based out of Taibei, Taiwan, 32945 locations across the world are running investigations on this particular treatment."
Answered by AI
How many health care centers are currently conducting this trial?
"There are 9 clinical trial sites recruiting patients, such as The University of Texas Southwestern Medical Center at Dallas in Dallas, Smilow Cancer Hospital at Yale New Haven in New Haven, and Sarah Cannon Research Institute in Nashville. Additionally, there are 6 other centers enrolling participants."
Answered by AI
How many individuals have enrolled in this research endeavor?
"Tempest Therapeutics is recruiting 320 individuals that meet the set inclusion criteria for this trial. It will be conducted across two sites, namely The University of Texas Southwestern Medical Center at Dallas and Smilow Cancer Hospital at Yale New Haven in Connecticut."
Answered by AI
Is enrollment for this trial ongoing?
"According to clinicaltrials.gov, this medical trial is open to enrolment; the listing was first published on November 2nd 2020 and has been edited recently (November 4th 2022)."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California San Francisco Cancer Center; Pharmacy
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I know I'm showing signs of liver disease can't really say what stage unless I get a biopsy.
PatientReceived no prior treatments
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