Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intratumoral Tavo and Pembro in Patients With Inoperable Locally Advanced or Metastatic TNBC (KEYNOTE-890)

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.
 
ClinicalTrials.gov Identifier: NCT03567720
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
OncoSec Medical Incorporated

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.

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 screening period, treatment period and a long-term follow-up.

Eligible subjects 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 up to 17 cycles of tavo-EP and 33 cycles of pembrolizumab from baseline (approximately 2 years) or until subsequent disease progression. As many accessible lesions may be treated, as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm.

Long-term Follow-up: All subjects will be followed after End of Study (EOS) visit for Serious Adverse Events (through 90 days from last dose of study drug) and long term survival status. EOS visit will occur 4 weeks after last study treatment administration


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 2, non-comparative, open-label, single-arm, multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tavo-EP plus IV pembrolizumab
Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous 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 Investigator review based on RECIST v1.1


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Approximately 2 years ]
    DOR by Investigator based on RECIST v1.1

  2. Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    PFS by Investigator based on RECIST v1.1

  3. Immune Progression Free Survival (iPFS) [ Time Frame: Approximately 2 years ]
    iPFS by Investigator review based on iRECIST

  4. Immune Objective Response Rate (iORR) [ Time Frame: Approximately 2 years ]
    iORR by Investigator review based on RECIST v1.1

  5. 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.


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

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.

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.

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): NCT03567720


Contacts
Layout table for location contacts
Contact: Donna Bannavong 858-210-7333 ext 535 dbannavong@oncosec.com
Contact: Kellie Malloy 609-977-4193 kmalloy@oncosec.com

Locations
Layout table for location information
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact    650-723-0658      
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact    813-745-5975      
Principal Investigator: Hatem Soliman, MD         
United States, Washington
University of Washington, Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
Contact    206-606-1809      
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact    +61 7 3176 3962      
Australia, South Australia
Calvary Central Districts Hospital Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact    +61 8 8282 5266      
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact    +61 3 9091 8804      
Sponsors and Collaborators
OncoSec Medical Incorporated
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Kellie Malloy OncoSec Medical Incorporated

Layout table for additonal information
Responsible Party: OncoSec Medical Incorporated
ClinicalTrials.gov Identifier: NCT03567720     History of Changes
Other Study ID Numbers: OMS-I141 (KEYNOTE-890)
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Metastatic
Inoperable Locally Advanced
TNBC
pIL-12
tavokinogene telseplasmid
pembrolizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents