A Study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab

Phase 1

• Conditions: nresectable hepatocellular carcinoma (HCC); MedDRA version: 21.0Level: LLTClassification code: 10019828Term: Hepatocellular carcinoma non-resectable Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503229-21-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients, ?Patients without cirrhosis require histological confirmation of diagnosis. HCC must be unamenable to curative surgical and/or locoregional therapies, or have progressed after surgical and /or locoregional therapies, ?Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 7 days prior to randomization, ?Child-Pugh class A within 7 days prior to randomization, ?Life expectancy of at least 12 weeks, ?Patients with active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 international units per milliliter (IU/mL) obtained within 28 days prior to initiation of study treatment and received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study

Exclusion Criteria

?Symptomatic, untreated, or actively progressing central nervous system metastases, ?History of leptomeningeal disease and hepatic encephalopathy, ?History of malignancy other than HCC within 5 years prior to screening, ?Significant cardiovascular disease within 3 months prior to initiation of study treatment, ?Known allergy or hypersensitivity to any of the investigational medicinal product (IMPs) or constituents of the products, ?Treatment with an investigational therapy within 28 days prior to initiation of study treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified