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Checkpoint Inhibitor
Durvalumab + Tremelimumab for Liver Cancer (SIERRA Trial)
Phase 3
Recruiting
Led By Stephen Chan, MD
Research Sponsored by AstraZeneca
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 the date of the first dose of imp until death [maximum follow-up approx. 33 months]
Awards & highlights
SIERRA Trial Summary
This trial will test a new cancer treatment to see if it is safe and effective for people with advanced liver cancer.
Who is the study for?
This trial is for adults with advanced unresectable hepatocellular carcinoma (HCC) who haven't had systemic therapy before. They should have a life expectancy of at least 12 weeks, good organ function, and measurable liver cancer lesions. It's open to those with certain stages of liver disease but excludes anyone with other active cancers, immune conditions, or severe heart issues.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two drugs—Durvalumab and Tremelimumab—as a first-line treatment for HCC. These medications are given in a specific regimen called STRIDE to see if they can help control the cancer better than current treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect organs like the liver or lungs, infusion reactions during drug administration, fatigue, nausea or vomiting, changes in blood counts leading to increased infection risk or bleeding problems.
SIERRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of the first dose of imp until death [maximum follow-up approx. 33 months]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of the first dose of imp until death [maximum follow-up approx. 33 months]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade 3 or 4 possibly related to treatment adverse events (PRAEs)
Objective response rate (ORR)
Secondary outcome measures
Best overall response for HRQoL as assessed by EORTC QLQ C-30
Best overall response for HRQoL as assessed by EORTC QLQ-HCC18
Change from baseline in HRQoL as assessed by EORTC QLQ C-30
+12 moreSIERRA Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab plus TremelimumabExperimental Treatment2 Interventions
Participants will receive a single priming dose of Tremelimumab plus Durvalumab at Day 1 (Week 0), followed by Durvalumab monotherapy starting at Week 4 and continuing until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or any intervention discontinuation criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,289 Previous Clinical Trials
288,620,058 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Stephen Chan, MDPrincipal InvestigatorDepartment of Clinical Oncology, Chinese University of Hong Kong
Lorenza Rimassa, MDPrincipal InvestigatorHumanitas Cancer Centre, IRCCS Humanitas Research Hospital
2 Previous Clinical Trials
89 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it fits the exceptions.I have a tumor that can be measured and has not been treated with radiation.My liver cancer diagnosis was confirmed through a tissue examination.I have tested positive for HIV or active tuberculosis.I have lasting side effects from cancer treatment that are moderate or worse.I have not had liver-related brain issues or needed medication for it in the last year.My organs and bone marrow are working well.I cannot have surgery for my liver cancer.My liver cancer is at an intermediate or advanced stage.I am receiving treatment for hepatitis B.I have or had an autoimmune or inflammatory disorder.I haven't taken immunosuppressive drugs in the last 14 days.I have had serious heart problems like heart failure, chest pain, or irregular heartbeat.I have hepatitis C confirmed by a positive test result.My liver function and physical ability meet the study's requirements.I am either post-menopausal or using birth control.I do not have any uncontrolled diseases or a history of organ transplant.I have been treated with immune therapies but not cancer vaccines.My partner and I use birth control.I have had cancer spread to the lining of my brain and spinal cord.I have had GI bleeding in the last 6 months.I have both hepatitis B and either hepatitis C or D.My body weight is over 30 kg.I have not had any drug treatments for liver cancer.My liver cancer is a specific type: fibrolamellar, sarcomatoid, or mixed with bile duct cancer.I have significant fluid buildup in my abdomen.I have had, or currently have, cancer spread to my brain or spinal cord.I have ongoing issues with nausea, vomiting, GI disease, swallowing, or had major bowel surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab plus Tremelimumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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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