BEACON - ABC in Recurrent Platinum Resistant HGSOC — BEACON  

Ovarian Cancer Clinical Trial

Official title: BEACON - A Phase II Study of Bevacizumab, Atezolizumab and Cobimetinib in Patients With Recurrent Platinum Resistant High Grade Serous Ovarian Cancer

Status Active, not recruiting

Clinical Trial Summary

Epithelial ovarian cancer (EOC) is the ninth most common cause of cancer in Australian women, with an estimated 1500 new diagnoses in Australia in 2015, and remains the seventh most common cause of cancer death in Australian women. High grade serous ovarian cancer (HGSC) is the most common form of Epithelial Ovarian Cancer, and accounts for the most deaths due to a gynaecological cancer.

The majority of women diagnosed with High Grade Serous Ovarian Cancer present with advanced disease, and are typically managed with a combination of cytoreductive surgery and platinum-based chemotherapy. Despite initial good response rates to chemotherapy, High Grade Serous Ovarian Cancer recurs in up to 70% of patients who present with Stage III/IV disease.

The purpose of this research project is to test how safe and effective the combination treatment of cobimetinib, bevacizumab and atezolizumab is as a treatment for patients with platinum resistant or refractory high grade serous ovarian, fallopian tube or peritoneal cancer.

Cobimetinib is a drug that blocks a protein called Mitogen-activated protein kinase (MEK). MEK proteins are involved in the multiplication of cancer cells. By binding to the MEK protein, cobimetinib may help to stop the growth of your cancer cells.

Bevacizumab is an antibody (a type of protein produced by the immune system) that is specifically designed to block a protein called Vascular Endothelial Growth Factor (VEGF). VEGF is a protein that can increase the growth of tumour cells and binding to VEGF may help to stop the growth of tumours.

Atezolizumab is a type of drug called a Programmed Cell Death Protein 1 (PD-L1) inhibitor. PD-L1 binds to PD-1 which is a type of protein found on the surface of cells in your body's immune system, and it controls the ability of your body's natural immune response to trigger the death of tumour cells. Tumour cells can hide from the immune system by using PD-L1, which stops your immune system from triggering tumour cell death.

Atezolizumab is a drug designed to block this PD-1/PD-L1 interaction by binding to PD-L1 so that PD-1 cannot bind to it and stops it from turning off your immune cells. This helps your immune system to recognise and destroy tumour cells. In turn, this potentially can stop or reverse the growth of your cancer.

Cobimetinib, bevacizumab and atezolizumab have been used alone or in combination in the treatment of many other cancers. Each of them are individually licensed for the treatment of cancers such as advanced melanoma, non-small cell lung cancer, and bladder cancer in Australia. However, this treatment combination is experimental and is not approved to treat ovarian, fallopian tube or peritoneal cancers in any country.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

• NCT number: NCT03363867
• Study type: Interventional
• Source: Peter MacCallum Cancer Centre, Australia
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 10, 2018
• Completion date: June 30, 2025