Moffitt logo

Clinical Trials Search

Clinical Trial 19755

Cancer Type: Breast
Interventions:Pembrolizumab (Keytruda); tavo-EP

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Hatem Soliman

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

Objective

To assess efficacy as measured by objective response rate (ORR) by Blinded1 Independent Central Review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of intratumoral tavo-EP in combination with pembrolizumab (collectively the combined treatment) in subjects with inoperable locally advanced or metastatic TNBC

Inclusion Criteria

  • Participants 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.
  • Participant must have estrogen (ER) receptor and progesterone (PR) receptor staining > Participant 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.
  • 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).
  • Adequate organ function as defined per protocol. All screening laboratories should be performed within 10 days of treatment initiation.
  • 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).
  • 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.
  • Able and willing to give informed consent and to follow study instructions.

  • Exclusion Criteria

  • Participant has a known additional malignancy that is progressing or requires active treatment.
  • Clinically active CNS metastases. Participants 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.
  • Participants who had an allogenic tissue/solid organ transplant
  • Participants with electronic pacemakers or defibrillators.
  • Participant who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Participants who have known to be positive for Hepatitis B antigen (e.g., HBsAg) or Hepatitis B virus (HBV) DNA or Hepatitis C (e.g.,antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative
  • Participant 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.
  • Participants 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.
  • Participant has severe hypersensitivity (≥Grade 3) to pembrolizumab or other anti-PD-1 monoclonal antibody therapy and/or any of its excipients.
  • Participants 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).
  • Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Participant has a history of interstitial lung disease.
  • Participant has an active infection requiring systemic therapy.
  • Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the Participant's participation for the full duration of the study, or is not in the best interest of the Participant to participate, in the opinion of the treating Investigator.
  • Participant has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events (AEs) due to a previously administered agent.
  • Participation in another clinical study of an investigational agent or has used an investigational device within 30 days of screening.
  • Participants 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.