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New treatment option for Hepatocellular Carcinoma
Official title Sequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients
ClinicalTrials.gov ID: NCT05844046
What this study is testing
What is durvalumab, tremelimumab, bevacizumab?
durvalumab, tremelimumab, bevacizumab is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, open-label, multi-center, international, Phase II study to assess the efficacy and safety of sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma. Patients will be randomized in a 1:1 ratio to one of the following arms: Arm A: initial treatment with durvalumab plus tremelimumab followed by treatment escalation with the addition of bevacizumab upon radiological progression or in the absence of objective response Arm B: up-front treatment with durvalumab, tremelimumab and bevacizumab Patients will be stratified according to macrovascular invasion and etiology of liver disease (viral etiologies versus others).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- KEY Age ≥18 years at the time of study entry
- Confirmed HCC based on histopathological findings from tumor tissues.
- Must not have received prior systemic therapy for HCC.
- Not eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must...
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
You likely can't join if
- Previous study drug(s) assignment in the present study.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
- Major surgical procedure or significant traumatic injury within 28 days prior to the first dose of study drug(s), abdominal surgery, abdominal...
- History of allogeneic organ transplantation (eg, liver transplant).
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
- Clinically meaningful ascites
See the full eligibility criteria
- KEY Age ≥18 years at the time of study entry
- Confirmed HCC based on histopathological findings from tumor tissues.
- Must not have received prior systemic therapy for HCC.
- Not eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan for the...
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
- Child-Pugh Score class A
- ECOG performance status of 0 or 1 at enrollment
- At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized...
- Adequate organ and marrow function
- Previous study drug(s) assignment in the present study.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
- Major surgical procedure or significant traumatic injury within 28 days prior to the first dose of study drug(s), abdominal surgery, abdominal interventions, or significant abdominal traumatic injury within 60 days...
- History of allogeneic organ transplantation (eg, liver transplant).
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
- Clinically meaningful ascites
- Patients with main portal vein thrombosis (i.e., thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.
- Patient currently exhibits symptomatic or uncontrolled hypertension
- Active or prior documented autoimmune or inflammatory disorders, diverticulitis. Patients without active disease in the last 5 years are excluded unless discussed with the Study Physician and considered appropriate for...
- Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV).
- History of another primary malignancy except for the exceptions defined by the study protocol.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- History of active primary immunodeficiency.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug(s). Note: Patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last...
- Major gastrointestinal bleeding within 4 weeks prior to randomization.
- Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding. Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and...
- Significant vascular disease including aortic aneurysm requiring surgical repair or peripheral arterial thrombosis with 6 months prior to randomization
- History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
- Evidence of bleeding diathesis or significant coagulopathy
- Severe, nonhealing or dehisced wound, active ulcer, or untreated bone fracture
- Current or recent (within 10 days of randomization) use of acetylsalicyclic acid (=\> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
- Current or recent (within 10 days prior to randomization) use of fulldose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose. Prophylactic use of low molecularweight heparin is allowed.
- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab...
- Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Germany
- Würzburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Germany; Würzburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.