Liver Cancer ML44719

This is a Phase II, open-label, multicohort, multicenter study in patients with unresectable, locally advanced, or metastatic HCC who have Child-Pugh B7 or B8 liver cirrhosis who have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety and efficacy of atezolizumab plus bevacizumab or atezolizumab monotherapy in this population.

Safety assessments will include the incidence, nature, and severity of adverse events and laboratory abnormalities graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). Laboratory safety assessments will include the regular monitoring of hematology and blood chemistry.

Patients will receive atezolizumab 1200 mg IV with (Cohort A) or without (Cohort B) bevacizumab 15 mg/kg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available and applicable), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease).

Criteria:

  1. Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed
  2. Disease that is not amenable to curative surgical and/or locoregional therapies
  3. No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
  4. Measurable disease (at least one untreated target lesion) according to RECIST v1.1
  5. ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
  6. Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
  7. Adequate hematologic and end-organ function
  8. Life expectancy of at least 12 weeks

Locations: Hartford Hospital, Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

Contacts: Hartford - Hayley Dunnack Yackel (Hayley.Dunnack@hhchealth.org 860-972-5518); HOCC - Siobhan Reilly (Siobhan.Reilly@hhchealth.org 860-696-4958)

Sponsor: Genentech, Inc.

Cancer Clinical Research Office