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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 year 1, year 2
Awards & highlights
SKYSCRAPER-14 Trial Summary
This trial tests a new combination therapy to treat unresectable liver cancer, looking at efficacy and safety.
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.Check my eligibility
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.See study design
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.
SKYSCRAPER-14 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1, year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1, year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-Assessed Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Overall Survival (OS)
Secondary outcome measures
Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30
Investigator-Assessed Confirmed ORR According to HCC mRECIST
Investigator-Assessed Confirmed Objective Response Rate (ORR) According to RECIST v1.1
+11 moreSKYSCRAPER-14 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
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,511 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
5,338 Patients Enrolled for Hepatocellular Carcinoma
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,054 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
221 Patients Enrolled for Hepatocellular Carcinoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,228 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
5,260 Patients Enrolled for Hepatocellular Carcinoma
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are testing the efficacy of this therapy?
"Affirmative. According to clinicaltrials.gov, the research project that was initially posted on August 28th 2023 is actively seeking volunteers; 650 participants are needed in total from a single medical centre."
Answered by AI
Are there any available opportunities to participate in this research?
"Affirmative. Clinicaltrials.gov has reported the commencement of this medical trial on August 28th 2023 with an update recently posted on August 10th of the same year."
Answered by AI
Has the combination of Atezolizumab, Bevacizumab, and Tiragolumab received regulatory approval?
"Our team at Power graded Atezolizumab + Bevacizumab + Tiragolumab's safety as a 3, due to the existence of efficacy research and reliable evidence surrounding its safety profile."
Answered by AI
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