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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

No Placebo-Only Group

Pivotal 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.

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.

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.

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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the first dose of imp until death [maximum follow-up approx. 33 months] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of grade 3 or 4 possibly related to treatment adverse events (PRAEs)

Objective response rate (ORR)

Secondary study objectives

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 more

Awards & Highlights

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.

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

~3750

Tremelimumab

2017

Completed Phase 2

~3070