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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03567720




Registration number
NCT03567720
Ethics application status
Date submitted
13/06/2018
Date registered
25/06/2018
Date last updated
8/03/2019

Titles & IDs
Public title
Intratumoral Tavo and Pembro in Patients With Inoperable Locally Advanced or Metastatic TNBC (KEYNOTE-890)
Scientific title
A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With IV Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (KEYNOTE-890)
Secondary ID [1] 0 0
OMS-I141 (KEYNOTE-890)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - tavokinogene telseplasmid
Other interventions - Pembrolizumab
Treatment: Devices - Immunopulse

Experimental: tavo-EP plus IV pembrolizumab - Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab


Other interventions: tavokinogene telseplasmid
Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks

Other interventions: Pembrolizumab
Intravenous 3 weekly treatments

Treatment: Devices: Immunopulse
Device that administers electroporation

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) - ORR by Investigator review based on RECIST v1.1
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Duration of Response (DOR) - DOR by Investigator based on RECIST v1.1
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - PFS by Investigator based on RECIST v1.1
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Immune Progression Free Survival (iPFS) - iPFS by Investigator review based on iRECIST
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Immune Objective Response Rate (iORR) - iORR by Investigator review based on RECIST v1.1
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Overall Survival - Overall Survival
Timepoint [5] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
1. Subjects with histologically confirmed diagnosis of inoperable locally advanced or
metastatic TNBC and at least 1 prior line of systemic chemotherapy or immunotherapy
that includes an approved regimen.

2. Subjects must have estrogen (ER) receptor and progesterone (PR) receptor staining <10%
and be human epidermal growth factor receptor 2 (HER2) -negative defined as
immunohistochemistry (IHC) 0 to 1+

3. Subjects must not have disease that, in the opinion of the Investigator, is considered
amenable to potentially curative treatment.

4. Age = 18 years of age of day of signing informed consent.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

6. Life expectancy of at least 6 months.

7. Have measurable disease based on RECIST v1.1, and at least one anatomically distinct
lesion involving skin or subcutaneous tissue accessible for electroporation of = 0.3
cm and lesion must be accurately measured in at least one dimension (longest diameter
in the plane of measurement is to be recorded).

8. Demonstrate adequate organ function as defined below. All screening laboratories
should be performed within 10 days of treatment initiation.

9. For women of childbearing potential, negative serum or urine pregnancy test within 72
hours prior to the first study drug administration. If the urine test is positive or
cannot be confirmed as negative, a serum pregnancy test will be required.

10. For women of childbearing potential, must be willing to use an adequate method of
contraception from 30 days prior to the first study drug administration and 120 days
following last day study drug administration (either tavo or pembrolizumab).
Acceptable methods include hormonal contraception (oral contraceptives - as long as on
stable dose, patch, implant, and injection), intrauterine devices, or double barrier
methods (e.g. vaginal diaphragm/ vaginal sponge plus condom, or condom plus
spermicidal jelly, if available), sexual abstinence or a vasectomized partner. Women
may be surgically sterile or at least 1-year post-last menstrual period.

11. Male subjects must be surgically sterile or must agree to use contraception during the
study and at least 120 days following the last day of study drug administration.

12. Able and willing to give informed consent and to follow study instructions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has a known additional malignancy that is progressing or requires active
treatment.

2. Clinically active CNS metastases. Subjects with previously treated brain metastases
may participate provided they are radiologically stable, i.e., without evidence of
progression for at least 4 weeks by repeat imaging (note that the repeat imaging
should be performed during study screening), clinically stable and without requirement
of steroid treatment for at least 14 days prior to first dose of study drug.

3. Subject who had an allogenic tissue/solid organ transplant

4. Subjects with electronic pacemakers or defibrillators.

5. Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV1/2
antibodies).

6. Subjects who are known to be positive for Hepatitis B antigen (HBsAg) or Hepatitis B
virus (HBV) DNA or Hepatitis C antibody or RNA. Active Hepatitis C is defined by a
known positive Hep C Ab result and known quantitative HCV RNA results greater than the
lower limits of detection of the assay.

7. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy (in dosing exceeding 10 mg/day of prednisone or equivalent) or any other form
of immunosuppressive therapy within 7 days prior to the first dose of study drug. The
use of physiologic doses of corticosteroids may be approved after consultation with
the Sponsor.

8. Subjects who have received a live-virus vaccination within 30 days of the first dose
of treatment. Seasonal flu vaccines that do not contain live virus are permitted.

9. Subject has severe hypersensitivity (=Grade 3) to pembrolizumab or other anti-PD-1
monoclonal antibody therapy and/or any of its excipients.

10. Subjects who have received transfusion of blood products (including platelets or red
blood cells) or colony stimulating factors (including G-CSF, GM-CSF or recombinant
erythropoietin) within 3 weeks prior to study Cycle 1, Day 1 (Baseline).

11. Subject has a history of (non-infectious) pneumonitis that required steroids or
current pneumonitis.

12. Subject has a history of interstitial lung disease.

13. Subject has an active infection requiring systemic therapy.

14. Subject has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating Investigator.

15. Subject has not recovered (i.e., = Grade 1 or at Baseline) from adverse events (AEs)
due to a previously administered agent.

16. Participation in another clinical study of an investigational anti-cancer agent or has
used an investigational device within 30 days of screening.

17. Subject has known psychiatric or substance abuse disorders that would interfere with
the subject's ability to cooperate with the requirements of the study.

18. Subjects who are pregnant or breastfeeding or expecting to conceive children within
the projected duration of the study, starting with the Screening visit through 120
days after the last dose of study treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
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 2
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)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Calvary Central Districts Hospital - Elizabeth Vale
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
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
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoSec Medical Incorporated
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This will be a Phase 2 study of intratumoral Tavokinogene Telseplasmid (tavo; pIL-12)
Electroporation (EP) plus pembrolizumab. Subjects with TNBC and EP accessible cutaneous /
subcutaneous disease will be enrolled in this study.
Trial website
https://clinicaltrials.gov/show/NCT03567720
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kellie Malloy
Address 0 0
OncoSec Medical Incorporated
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Donna Bannavong
Address 0 0
Country 0 0
Phone 0 0
858-210-7333
Fax 0 0
Email 0 0
dbannavong@oncosec.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03567720