Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer with Liver Metastases
Study Details
Approximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland.
The goal of this study is to evaluate the safety of intrahepatic injection (directly into the liver) of talimogene laherparepvec in combination with intravenously administered atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver metastases.
Protocol Summary
Subject’s incidence of dose limiting toxicities (DLTs)
Timeframe: At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Best overall response (BOR)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Duration of response (DOR)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Disease control rate (DCR)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Durable response rate (DRR)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Progression-free survival (PFS)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Overall survival (OS)
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months
Lesion level responses in injected and uninjected tumor lesions
Timeframe: Every 12 weeks (± 28 days) for approximately 24 months