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Closed (no longer recruiting)Last updated: 2 May 2024

IMbrave050: This phase III trial is trying to understand how safe and effective an adjuvant therapy is compared to active surveillance in patients that have had their hepatocellular (liver) cancer removed or destroyed and who have a high risk of their cancer coming backA Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Clinical summary

Summary

Eligible patients will be randomised to receive adjuvant therapy with Atezolizumab and Bevacizumab, or active surveillance until disease recurrence or toxicity.

Conditions

This trial is treating patients with hepatocellular (liver) cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

IMbrave050

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Eligibility

Inclusion

  • Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only) within 4-12 weeks prior to randomization
  • Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only)
  • Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread
  • Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure
  • Full recovery from surgical resection or ablation within 4 weeks prior to randomization
  • High risk for HCC recurrence after resection or ablation
  • For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
  • For patients with resected HCC, availability of a representative baseline tumor tissue sample
  • ECOG Performance Status of 0 or 1
  • Child-Pugh Class A status
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Evidence of residual, recurrent, or metastatic disease at randomization
  • Clinically significant ascites
  • History of hepatic encephalopathy
  • Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
  • Have received more than 1 cycle of adjuvant TACE following surgical resection
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Active tuberculosis
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1.
  • Co-infection with HBV and HCV
  • Co-infection with HBV and hepatitis D viral infection
  • Clinical significant uncontrolled or symptomatic hypercalcemia
  • Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE
  • Treatment with systemic immunostimulatory or immunosuppressive agents
  • Inadequately controlled arterial hypertension
  • History of hypertensive crisis or hypertensive encephalopathy
  • Significant vascular disease
  • Evidence of bleeding diathesis or significant coagulopathy
  • Current or recent use of aspirin or full-dose oral or parenteral anticoagulants
  • Core biopsy within 3 days of Day 1 of Cycle 1
  • History of GI fistula, GI perforation, or intra-abdominal abscess
  • Serious non-healing or dehiscing wound
  • Major surgical procedure within four weeks
  • Chronic daily treatment with a non-steroidal anti-inflammatory drug

Inclusion

  • Your cancer has not spread to other parts of the body.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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