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

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ClinicalTrials.gov Identifier: NCT03256344
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
Amgen

Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Triple Negative Breast Cancer Metastatic Colorectal Cancer Biological: Talimogene Laherparepvec Biological: Atezolizumab Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 9, 2020
Estimated Study Completion Date : May 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Talimogene Laherparepvec with Atezolizumab
Talimogene laherparepvec given by intralesional injection on Day one and every 21 days per protocol for a maximum on 12 cycles. Atezolizumab given by intravenous injection on Day one and every 21 days per protocol
Biological: Talimogene Laherparepvec
Virally based anti-cancer immunotherapy given by direct injection into tumors.
Other Name: IMLYGIC

Biological: Atezolizumab
A monoclonal antibody given by intravenous injection.
Other Name: MPDL3280A




Primary Outcome Measures :
  1. Subject's incidence of dose limiting toxicities (DLTs) [ Time Frame: At the end of Cycle 2 (each cycle is 21 days) ]
    To evaluate safety of talimogene laherparepvec as assessed by incidence of DLTs

  2. Subject's incidence of treatment-emergent adverse events [ Time Frame: Start of treatment through 30 (+7) days after the end of treatment ]
  3. Number of subject with clinically relevant laboratory abnormalities [ Time Frame: Start of treatment through 30 (+7) days after the end of treatment ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  2. Best overall response (BOR) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  3. Duration of response (DOR) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  4. Disease control rate (DCR) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  5. Durable response rate (DRR) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  6. Progression-free survival (PFS) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
    Response evaluation by Investigator using irRC-RECIST

  7. Overall survival (OS) [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]
  8. Lesion level responses in injected and uninjected tumor lesions [ Time Frame: Every 12 weeks (± 28 days) for approximately 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 wks 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 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.
  • Other Medical Conditions as noted in the protocol.
  • Criteria 7, Other Exclusion Criteria May Apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256344


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Los Angeles, California, United States, 90095
United States, New York
Research Site Recruiting
New York, New York, United States, 10032
Research Site Recruiting
Stony Brook, New York, United States, 11794-9446
Australia, New South Wales
Research Site Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Research Site Recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Research Site Recruiting
Murdoch, Western Australia, Australia, 6150
Research Site Recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Research Site Recruiting
Bruxelles, Belgium, 1200
Research Site Recruiting
Gent, Belgium, 9000
Germany
Research Site Recruiting
Berlin, Germany, 13353
Research Site Recruiting
Bonn, Germany, 53105
Research Site Recruiting
Tübingen, Germany, 72076
Spain
Research Site Recruiting
Barcelona, Cataluña, Spain, 08003
Research Site Recruiting
Madrid, Spain, 28007
Research Site Recruiting
Madrid, Spain, 28034
Switzerland
Research Site Recruiting
Bern, Switzerland, 3010
Research Site Recruiting
Geneva 14, Switzerland, 1211
Sponsors and Collaborators
Amgen
Roche-Genentech
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03256344     History of Changes
Other Study ID Numbers: 20140299
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Liver Metastases
Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Breast Diseases
Skin Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Atezolizumab
Talimogene laherparepvec
Antibodies, Monoclonal
Immunologic Factors