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Triple Negative Breast CancerPhase 2NCT03567720

Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

A Phase 2 study testing tavokinogene telseplasmid, Pembrolizumab and Immunopulse in people with Triple Negative Breast Cancer, run by OncoSec Medical Incorporated at 14 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
tavokinogene telseplasmid, Pembrolizumab and Immunopulse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
14 sitesin 2 countries
Study dates
11 Oct 2018to Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC.
  • The following prior cancer therapy requirements apply to specific cohorts:
  • For Cohort 1 only, subjects must have received at least 1 prior line of systemic chemotherapy or immunotherapy that includes an approved regimen.
  • For Cohort 2 only, subjects has had no prior systemic therapy in the advanced/metastatic setting and must not have progression or recurrence of disease within 6 months after the last dose of systemic neoadjuvant or adjuvant treatment, if applicable.
  • Subjects must have TNBC defined as estrogen (ER) receptor and progesterone (PR) receptor staining <10% and human epidermal growth factor receptor 2 (HER2) - negative defined as immunohistochemistry (IHC) 0 to 1+
  • For Cohort 2, the participant must meet each of the following criteria:
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  • Has baseline PD-L1 negative disease (defined as Dako 22C3 assay CPS<10 [or equivalent, per sponsor agreement]) with results provided prior to start of study drug dosing: Historic results or new local PD-L1 testing from tissue collected within 6 months and without intervening therapy prior to Cycle 1 Day 1
  • Can provide a separate core or punch tumor biopsy collected at screening or archival tissue collected within 6 months (and without intervening therapy) prior to Cycle 1 Day 1
  • Has at least one lesion suitable for biopsy on Cycle 2 Day 1 (preferably same lesion from which the screening sample was collected).
  • Subjects must not have disease that, in the opinion of the Investigator, is considered amenable to potentially curative treatment.
  • Age ≥ 18 years of age of day of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Life expectancy of at least 6 months.
  • Participant has measurable disease based on RECIST v1.1 and has at least one identified lesion (target or non-target) that is accessible (up to 1.5 cm from the skin surface) and in a safe location for intratumoral injection and electroporation.
  • Demonstrate adequate organ function. All screening laboratories should be performed within 10 days of treatment initiation.
  • Female participant of childbearing potential must have a negative pregnancy test (for serum or urine pregnancy test, within 72 hours or 24 hours, respectively, prior to receiving the first study drug administration). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female participant of childbearing potential must be willing to use an adequate method of contraception from the first day of study treatment (or 14 days prior to the initiation of study treatment for oral contraception) and through at least 120 days following the last day of study treatment.
  • Male participant is surgically sterile OR agrees to use an adequate method of contraception when having sex with women of childbearing potential and refrains from sperm donation during the study treatment period and at least 120 days following the last day of study treatment.
  • Participant is able and willing to give informed consent and to follow study instructions.

Who cannot join

  • Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Subject has a clinically active brain metastases or leptomeningeal metastases. Participant who has a previously treated brain metastases or untreated asymptomatic brain metastases ≤5 mm may participate provided that they are radiologically stable (ie, without evidence of progression based on imaging during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.
  • Subject has had an allogenic tissue/solid organ transplant.
  • Subjects with electronic pacemakers or defibrillators.
  • Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Subject has active hepatitis B (defined as HBsAg reactive) or active hepatitis C (defined as HCV RNA [qualitative] is detected). Note: Participant with a history of HBV or HCV controlled by ongoing viral suppression therapy is allowed.
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  • 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.
  • Subject has an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Subject has received a live-virus or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
  • Seasonal flu vaccines and COVID-19 vaccines that do not contain live virus (including attenuated vaccines) are permitted.
  • Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab or other anti-PD-1 monoclonal antibody therapy and/or any of its excipients.
  • For Cohort 2 only, participant has severe hypersensitivity (≥Grade 3) to or expected intolerance of the protocol-specified chemotherapy options. Participant must be able to tolerate at least one of the trial approved chemotherapy options.
  • Subject has received transfusion of blood products (including platelets or red blood cells) or colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 2 weeks prior to qualifying screening labs.
  • Subject has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Subject has a history of interstitial lung disease.
  • Subject has an active infection requiring systemic therapy.
  • 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.
  • Participant has not recovered (ie, ≤Grade 1 or at baseline) from adverse events (AEs) due to a previously administered agent.
  • Subject has received any systemic anti-cancer agent or other local anti-cancer immunotherapy within 14 days prior to the start of study treatment.
  • Subject has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States10 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • UC San Diego

    La Jolla, California, 92093

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • University of Washington, Seattle Cancer Care Alliance

    Seattle, Washington, 98195

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • The Lundquist Institute

    Torrance, California, 90502

  • University of Arizona

    Tucson, Arizona, 85719

Other trials in United States

Australia4 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Calvary Central Districts Hospital

    Elizabeth Vale, South Australia, 5112

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Phase 2 Multi-Cohort, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Pembrolizumab +/- Chemotherapy in Patients With Inoperable Locally Advanced/Metastatic Triple-Negative Breast Cancer

This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting will be enrolled in this study.

Read the detailed description

The study will include a screening period, treatment period (up to 2 years), a long-term follow-up period, and a survival follow-up period. Participants will be followed for disease status and survival for up to a total duration of 5 years from the time of first dose of study treatment.

Eligible subjects with accessible lesions will be treated with TAVO-EP on Days 1, 5 and 8 every 6 weeks for up to 18 weeks. Pembrolizumab IV will be administered at a dose of 200 mg on Day 1 every 3-weeks for up to 35 cycles (Q3W) or 400 mg on Day 1 every 6 weeks for up to 18 cycles (Q6W).

Eligible subjects will be enrolled in one of the following cohorts.

  • Cohort 1 is a single-arm study of intratumoral TAVO-EP and pembrolizumab (Q3W) in participants with TNBC and at least 1 line of prior systemic therapy in the advanced or metastatic setting.
  • Cohort 2 is a single-arm study of intratumoral TAVO-EP and pembrolizumab along with treatment with an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®)or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting. Participants enrolled on or after Protocol Version 7 will have baseline disease PD-L1 negative status defined as Dako 22C3 assay CPS <10.

For participants in Cohort 2 receiving nab-paclitaxel, the schedule for nab-paclitaxel is a separate 28-day cycle. The dosing regimen of nab-paclitaxel is 100 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

For participants in Cohort 2 receiving gemcitabine plus carboplatin, the dosing regimen is gemcitabine 1000 mg/m² plus carboplatin area under the curve (AUC) 2 IV on Days 1 and 8 every 21 days.

Being tested
tavokinogene telseplasmid, Pembrolizumab, Immunopulse, nab paclitaxel, gemcitabine plus carboplatin
Keywords
Metastatic, Inoperable Locally Advanced, TNBC, plasmid interleukin-12, tavokinogene telseplasmid, pembrolizumab, chemotherapy, pIL-12, Nab-paclitaxel, gemcitabine plus carboplatin, IL-12, IL12
Medical subject headings
Triple Negative Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tavokinogene telseplasmidBiological

    Also called pIL-12, tavo-EP

    Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks

  • PembrolizumabBiological

    Also called Keytruda

    Intravenous 3 weekly treatments

  • ImmunopulseDevice

    Also called tavo-EP

    Device that administers electroporation

  • nab paclitaxelDrug

    Also called Abraxane

    intravenous on days 1, 8 and 15 of each 28 day cycle

  • gemcitabine plus carboplatinDrug

    Also called Gemzar, Paraplatin

    intravenous on days 1 and 8 of every 21 days

Study groups in NCT03567720
Study groupRoleWhat they receive
TAVO-EP plus IV pembrolizumabExperimentalIntratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab (Cohort enrollment completed)
Receives: Biological: tavokinogene telseplasmid; Biological: Pembrolizumab; Device: Immunopulse
TAVO-EP plus IV pembrolizumab with chemotherapyExperimentalIntratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel or gemcitabine plus carboplatin)
Receives: Biological: tavokinogene telseplasmid; Biological: Pembrolizumab; Device: Immunopulse; Drug: nab paclitaxel; Drug: gemcitabine plus carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: Objective Response Rate (ORR)

    ORR by Investigator review based on RECIST v1.1

    Measured: Approximately 2 years

  2. Cohort 2: Objective Response Rate (ORR)

    ORR by Investigator review based on RECIST v1.1

    Measured: Approximately 2 years

Secondary outcomes (6)

  1. Duration of Response (DOR)

    Cohort 1 \& Cohort 2: DOR by Investigator based on RECIST v1.1

    Measured: Approximately 2 years

  2. Progression Free Survival (PFS)

    Cohort 1 \& Cohort 2: PFS by Investigator based on RECIST v1.1

    Measured: Approximately 2 years

  3. Immune Progression Free Survival (iPFS)

    Cohort 1 \& Cohort 2: iPFS by Investigator review based on iRECIST

    Measured: Approximately 2 years

  4. Immune Objective Response Rate (iORR)

    Cohort 1 \& Cohort 2: iORR by Investigator review based on iRECIST

    Measured: Approximately 2 years

  5. Disease Control Rate (DCR)

    Cohort 1 \& Cohort 2: DCR by Investigator based on RECIST v1.1

    Measured: Approximately 2 years

  6. Overall Survival

    Cohorts 1 and 2: Overall Survival for Cohorts

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start11 Oct 2018
  3. Primary completionApr 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Phase 2, Multi-Cohort, Open-Label, Multi-Center Study
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567720
Sponsor's protocol ID
OMS-I141 (KEYNOTE-890)
Other IDs
KEYNOTE-890, MK3475-890
Status last verified
May 2023
First submitted
13 Jun 2018
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Jacobs L, Yshii L, Junius S, Geukens N, Liston A, Hollevoet K, Declerck P. Intratumoral DNA-based delivery of checkpoint-inhibiting antibodies and interleukin 12 triggers T cell infiltration and anti-tumor response. Cancer Gene Ther. 2022 Jul;29(7):984-992. doi: 10.1038/s41417-021-00403-8. Epub 2021 Nov 9.

    PubMed 34754076

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tavokinogene telseplasmid, Pembrolizumab and Immunopulse in people with Triple Negative Breast Cancer, run by OncoSec Medical Incorporated at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Objective Response Rate (ORR) (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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