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Monoclonal Antibodies
Atezolizumab + Bevacizumab +/- Tiragolumab for Liver Cancer (SKYSCRAPER-14 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 36 months
Awards & highlights
Summary
This trial is testing a combination of three drugs—tiragolumab, atezolizumab, and bevacizumab—to treat advanced liver cancer that cannot be removed by surgery. These drugs help the immune system fight cancer and cut off the tumor's blood supply. The goal is to see if this combination is safe and effective for these patients.
Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had systemic treatment before. They should be in good enough health to participate, not have a history of certain lung or autoimmune diseases, and can't be pregnant or breastfeeding. Men and women must use contraception to prevent pregnancy during the trial.
What is being tested?
The study tests tiragolumab combined with atezolizumab and bevacizumab as a first-line treatment for liver cancer. Participants will either receive this combination or a placebo alongside standard treatments to compare effectiveness and safety.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions, increased risk of infections, bleeding issues due to blood vessel growth inhibition by Bevacizumab, fatigue, and potential complications in patients with hepatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to approximately 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer 30 (QLQ-C30) Subscales
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab + Bevacizumab + TiragolumabExperimental Treatment3 Interventions
Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Group II: Atezolizumab + Bevacizumab + PlaceboPlacebo Group3 Interventions
Atezolizumab, bevacizumab plus placebo will be administered every 3 weeks (Q3W) 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
~5850
Tiragolumab
2019
Completed Phase 3
~1400
Bevacizumab
2013
Completed Phase 4
~5540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Hepatocellular Carcinoma (HCC) include immune checkpoint inhibitors like Atezolizumab and anti-angiogenic agents like Bevacizumab. Atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells.
Bevacizumab inhibits vascular endothelial growth factor (VEGF), reducing the blood supply to tumors and thereby inhibiting their growth. Tiragolumab, an anti-TIGIT monoclonal antibody, is being studied for its potential to enhance the immune response against cancer cells by blocking TIGIT, a protein that suppresses immune activity.
These mechanisms are crucial for HCC patients as they offer targeted approaches to slow tumor progression and potentially improve survival rates.
Angiogenesis Inhibitors for the Treatment of Hepatocellular Carcinoma.
Angiogenesis Inhibitors for the Treatment of Hepatocellular Carcinoma.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,092,472 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
5,338 Patients Enrolled for Hepatocellular Carcinoma
Chugai PharmaceuticalIndustry Sponsor
96 Previous Clinical Trials
21,380 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
221 Patients Enrolled for Hepatocellular Carcinoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
891,766 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
5,260 Patients Enrolled for Hepatocellular Carcinoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had bleeding from esophageal or stomach varices in the last 6 months.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have had lung conditions like pulmonary fibrosis or pneumonitis.I am co-infected with both hepatitis B and C.My liver function is classified as Child-Pugh Class A.I have untreated or partially treated varices in my esophagus or stomach that may bleed.I will use protection or abstain from sex to prevent pregnancy during and after treatment.I haven't had cancer, other than liver cancer, in the last 5 years.I am fully active or restricted in physically strenuous activity but can do light work.I am currently taking medication that suppresses my immune system.I have an active Epstein-Barr virus infection.I have brain metastases that are untreated or getting worse.My liver cancer is a specific type, not the common kind.My blood and organs are functioning well.My liver cancer is advanced, can't be removed by surgery, and is confirmed by tests or clinical criteria.I haven't had any systemic treatment for my advanced liver cancer.I am currently receiving treatment that boosts my immune system.I have had liver therapy within the last 28 days or am still experiencing side effects.My condition cannot be cured with surgery or local treatments.I have or had an autoimmune disease or immune deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab + Bevacizumab + Tiragolumab
- Group 2: Atezolizumab + Bevacizumab + Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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