Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

NCT03256344 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-05-14

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Talimogene Laherparepvec

Virally based anti-cancer immunotherapy given by direct injection into tumors.

BIOLOGICAL

Atezolizumab

A monoclonal antibody given by intravenous injection.

Sponsors & Collaborators

  • Roche-Genentech

    collaborator INDUSTRY
  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2020-05-26
Completion
2021-12-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Spain
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03256344 on ClinicalTrials.gov