Trial record 1 of 1 for:    NCT03567720
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Intratumoral Tavo and Pembro in Patients With Inoperable Locally Advanced or Metastatic TNBC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03567720
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
OncoSec Medical Incorporated

Brief Summary:
This will be a Phase 2, Simon 2-stage minimax design, non-comparative, open-label, single-arm, multicenter study of intratumoral Tavokinogene Telseplasmid Plus Electroporation (tavo-EP) plus pembrolizumab therapy ("combined treatment"). Subjects with TNBC and EP accessible cutaneous / subcutaneous disease will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Biological: tavokinogene telseplasmid Biological: Pembrolizumab Device: Immunopulse Phase 2

Detailed Description:

The study will be comprised of a Core study (27 weeks), an Extension Phase and a long-term follow-up.

Core Study: Eligible patients will be treated with intratumoral tavo-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for 24 weeks. As many accessible lesions, may be treated, as deemed feasible by the treating physician.

Extension Phase: Patients who completed 27 weeks of treatment (Core study) with the investigators discretion, will enter an Extension phase and continue to receive the combined treatment of intratumoral tavo-EP and pembrolizumab for up to 35 cycles of pembrolizumab from baseline (approximately 2 years) or until subsequent disease progression.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: intratumoral tavo-EP plus IV pembrolizumab
intratumoral tavo-EP plus IV pembrolizumab
Biological: tavokinogene telseplasmid
Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks
Other Names:
  • pIL-12
  • tavo-EP

Biological: Pembrolizumab
Intravenous 3 weekly treatments
Other Name: Keytruda

Device: Immunopulse
Device that administers electroporation
Other Name: tavo-EP

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    ORR by independent central review based on RECIST v1.1

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Within 24 weeks and approximately 2 years ]
    ORR by investigator review based on RECIST v1.1 and iRECIST

  2. Duration of Response (DOR) [ Time Frame: Within 24 weeks ]
    DOR by investigator independent central review based on RECIST v1.1 and iRECIST

  3. Duration of Response (DOR) [ Time Frame: Within 24 weeks and approximately 2 years ]
    DOR by investigator review based on RECIST v1.1 and iRECIST

  4. Progression Free Survival (PFS) [ Time Frame: Within 24 weeks ]
    PFS by independent central review based on RECIST v1.1 and iRECIST

  5. Progression Free Survival (PFS) [ Time Frame: Within 24 weeks and approximately 2 years ]
    PFS by investigator review based on RECIST v1.1 and iRECIST

  6. Overall Survival [ Time Frame: Approximately 2 years ]
    Overall Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy.
  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.

    - Absolute neutrophil count (ANC) ≥1.5 × 109/L; Platelets ≥100 × 109/L; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L*; Creatinine OR Measured or calculated** creatinine clearance (CrCl) Glomerular filtration rate (GFR) can also be used instead of creatinine or CrCl ≤1.5 × the upper limit of normal (ULN) OR > 60 mL/min for subject with creatinine levels >1.5 × institutional ULN; Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels > 1.5× ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases); International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

    * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks

    ** Creatinine clearance should be calculated per institutional standard.

  9. For women of childbearing potential, negative serum or urine pregnancy test within 72 hours of to the first study drug administration, and 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).
  10. 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.
  11. Able and willing to give informed consent and to follow study instructions.

Exclusion Criteria:

  1. Subject has a known additional malignancy that is progressing or requires active treatment.
  2. Clinically active CNS metastases or any non-measurable bone-only 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. Subjects with electronic pacemakers or defibrillators.
  4. Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  5. Subjects who have known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  6. 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.
  7. 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.
  8. Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab or other anti-PD-1 monoclonal antibody therapy and/or any of its excipients.
  9. Subjects who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 3 weeks prior to study Cycle 1, Day 1 (Baseline).
  10. Subject has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  11. Subject has a history of interstitial lung disease.
  12. Subject has an active infection requiring systemic therapy.
  13. 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.
  14. Subject has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events (AEs) due to a previously administered agent.
  15. Participation in another clinical study of an investigational agent or has used an investigational device within 30 days of screening.
  16. Subjects who are 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.

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 identifier (NCT number): NCT03567720

Contact: Kellie Malloy 609-977-4193

United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact    650-723-0658      
Sponsors and Collaborators
OncoSec Medical Incorporated
Study Director: Kellie Malloy OncoSec Medical Incorporated

Responsible Party: OncoSec Medical Incorporated Identifier: NCT03567720     History of Changes
Other Study ID Numbers: OMS-I141
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is a DSMB charter that make anonymised data available.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by OncoSec Medical Incorporated:
Inoperable Locally Advanced
tavokinogene telseplasmid

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents