Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Condition: Metastatic Triple Negative Breast Cancer; Metastatic Colorectal Cancer
MeSH terms: Breast Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms
Intervention: Talimogene Laherparepvec; Atezolizumab
Intervention description: Virally based anti-cancer immunotherapy given by direct injection into tumors.; A monoclonal antibody given by intravenous injection.
Intervention MeSH terms: Atezolizumab; Talimogene laherparepvec
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Liver Metastases

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Criteria1, Participant provided informed consent prior to any study-specific
             activities/procedures.

          -  Criteria 2, Confirmation of triple negative breast cancer or colorectal cancer with
             liver metastases by laboratory testing.

          -  Criteria 3, Subjects with triple negative breast cancer with liver metastases, or
             subjects with colorectal cancer with liver metastases are eligible if they have had
             disease progression during or after one or more prior standard of care systemic
             anti-cancer therapy (eg,chemotherapy, targeted therapy) for metastatic disease or if
             they progress during or within 6 months of receiving adjuvant therapy. If subjects, in
             the opinion of the investigator, are deemed not appropriate candidates for systemic
             anti-cancer therapy for metastatic disease or if they refuse systemic anti-cancer
             therapy for metastatic disease, they may be eligible after investigator discussion
             with Sponsor medical monitor for approval.

          -  Criteria 4, Participants have measurable disease which is equal to one or more
             metastatic liver lesions that can be accurately and serially measured that are greater
             than or equal to 1 cm dimension and for which the longest diameter is greater or equal
             to 1 cm as measured by CT (Computed Tomography) scan or magnetic resonance imaging.
             The metastatic liver lesion(s) must not be in an area that received prior localized
             therapies.

          -  Criteria 5, Metastatic liver lesions for injection must be without necrosis (dead
             tissue )and must be be located where any tumor swelling will not lead to gall bladder
             tract obstruction or lead to bleeding risk.

          -  Criteria 6, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.

          -  Criteria 7, Life expectancy greater than or equal to 5 months.

          -  Criteria 8, Adequate organ function within 4 weeks prior to enrollment. This includes
             hematology, renal, hepatic and blood-clotting functions as defined by protocol.

          -  Criteria 9, Female subjects of childbearing potential should have a negative serum
             pregnancy test within 1 week prior to enrollment.

          -  Criteria 10, Other Inclusion Criteria May Apply.

        Exclusion criteria:

          -  Criteria 1, Participant is a candidate for hepatic surgery or local regional therapy
             of liver metastases with curative intent.

          -  Criteria 2, More than one third of the liver is estimated to be involved with
             metastases.

          -  Criteria 3, There is invasion by cancer into the main blood vessels such as the portal
             vein, hepatic vein or the vena cava.

          -  Criteria 4, Participant is currently receiving or has received liver
             metastatic-directed therapy ( eg: radiation, ablation, embolization) less than 4 wks
             prior to enrollment or hepatic surgery.

          -  Criteria 5, History of other malignancy within the past 5 years prior to enrollment
             with some exceptions, as outlined in the protocol.

          -  Criteria 6, Active or untreated central nervous system (CNS) metastases per CT or
             magnetic resonance imagine (MRI) evaluation during screening.

          -  Participants with a history of CNS metastases are eligible provided they are stable
             and meet the criteria details in the protocol.

          -  Criteria 7, Other Medical Conditions as noted in the protocol.

          -  Criteria 8, Other Exclusion Criteria May Apply.