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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03256344




Registration number
NCT03256344
Ethics application status
Date submitted
8/08/2017
Date registered
22/08/2017
Date last updated
28/05/2020

Titles & IDs
Public title
Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Scientific 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
Secondary ID [1] 0 0
20140299
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Triple Negative Breast Cancer 0 0
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Talimogene Laherparepvec
Other interventions - Atezolizumab

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


Other interventions: Talimogene Laherparepvec
Virally based anti-cancer immunotherapy given by direct injection into tumors.

Other interventions: Atezolizumab
A monoclonal antibody given by intravenous injection.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject's incidence of dose limiting toxicities (DLTs) - To evaluate safety of talimogene laherparepvec as assessed by incidence of DLTs
Timepoint [1] 0 0
At the end of Cycle 2 (each cycle is 21 days)
Primary outcome [2] 0 0
Subject's incidence of treatment-emergent adverse events
Timepoint [2] 0 0
Start of treatment through 30 (+7) days after the end of treatment
Primary outcome [3] 0 0
Number of subject with clinically relevant laboratory abnormalities
Timepoint [3] 0 0
Start of treatment through 30 (+7) days after the end of treatment
Secondary outcome [1] 0 0
Objective response rate (ORR) - Response evaluation by Investigator using irRC-RECIST
Timepoint [1] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [2] 0 0
Best overall response (BOR) - Response evaluation by Investigator using irRC-RECIST
Timepoint [2] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [3] 0 0
Duration of response (DOR) - Response evaluation by Investigator using irRC-RECIST
Timepoint [3] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [4] 0 0
Disease control rate (DCR) - Response evaluation by Investigator using irRC-RECIST
Timepoint [4] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [5] 0 0
Durable response rate (DRR) - Response evaluation by Investigator using irRC-RECIST
Timepoint [5] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [6] 0 0
Progression-free survival (PFS) - Response evaluation by Investigator using irRC-RECIST
Timepoint [6] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Every 12 weeks (± 28 days) for approximately 24 months
Secondary outcome [8] 0 0
Lesion level responses in injected and uninjected tumor lesions
Timepoint [8] 0 0
Every 12 weeks (± 28 days) for approximately 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Bonn
Country [7] 0 0
Germany
State/province [7] 0 0
Tübingen
Country [8] 0 0
Spain
State/province [8] 0 0
Cataluña
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Switzerland
State/province [10] 0 0
Bern
Country [11] 0 0
Switzerland
State/province [11] 0 0
Geneva 14

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Roche-Genentech
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03256344
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03256344