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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT03256344
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer
  • Metastatic Triple Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Talimogene Laherparepvec — BIOLOGICAL
    Virally based anti-cancer immunotherapy given by direct injection into tumors.
  • Atezolizumab — BIOLOGICAL
    A monoclonal antibody given by intravenous injection.

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.

Key Dates

Start date
Mar 19, 2018
Status verified
May 2024
Primary completion
May 26, 2020
Completion
Dec 3, 2021

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Talimogene Laherparepvec with Atezolizumab: Triple Negative Breast Cancer (TNBC)
    Participants with TNBC with liver metastases administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle is 21 days. Participants administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
  • Experimental: Talimogene Laherparepvec with Atezolizumab: Colorectal Cancer (CRC)
    Participants with CRC with liver metastases administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle is 21 days. Participants administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.

Primary Outcome Measure

Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) [ Time Frame: From Day 1 up to the start of Cycle 3 (each cycle is 21 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
Columbia University Medical CenterNew YorkNew York10032-
Stony Brook UniversityStony BrookNew York11794-9446-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAColumbia University Medical Center· New York, NYStony Brook University· Stony Brook, NY

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