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Clinical Trial 19500

Cancer Type: Cutaneous
Interventions:IFx-Hu2.0

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Joseph Markowitz

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

Study Title

Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients with Unresectable Stage III or Stage IV Cutaneous Melanoma

Summary

Objective

Primary: To assess safety and feasibility Secondary: To assess any antitumor response

Inclusion Criteria

  • Histologically confirmed unresectable stage III or stage IV malignant melanoma, with accessible cutaneous lesions
  • Must have measurable disease greater than 3 mm
  • At least one injectable lesion and one lesion for biopsy at study conclusion. Lymphocyte count ≥ 500,000 cells/mL
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Willing and able to give written, informed consent
  • If male or female of childbearing potential must be willing to use a contraceptive during the study and for six months afterward. A woman is considered to be of childbearing potential unless she has had a surgical procedure that would accomplish sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the past 12 months.
  • Life expectancy greater than three months
  • To be eligible for this study, patients with unresectable metastatic disease must have failed, refused or been deemed not candidates for at least one form of systemic anti-PD-1-based immunotherapy as well as BRAF inhibition, if BRAF V600 mutated.
  • Patients with unresectable cutaneous, subcutaneous, and nodal melanoma lesions recurrent after initial surgery must have failed, refused or been deemed not candidates for talimogene laherparepvec to be eligible for this study.
  • The entry laboratory criteria for subject eligibility must be less than or equal to grade 1 adverse event levels for the parameters tested as defined by CTCAE v5.0.

  • Exclusion Criteria

  • Known brain metastases greater than 1 cm at screening.
  • Prior systemic anti-cancer treatment within three weeks from start of treatment (Day 0)
  • Current treatment with systemic immunosuppressive corticosteroid (greater than 10 mg of daily prednisone) doses or other immunosuppressants such as those needed for solid organ transplants. Medications needed to treat conditions such as reactive airway disease are not excluded.
  • Pregnant or lactating women
  • Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments
  • Treatment with any investigational product within the three weeks preceding injection
  • Immunizations for encapsulated bacteria were not given for patients who have undergone a splenectomy.
  • Serious underlying medical or psychiatric conditions, active infections requiring the use of antimicrobial drugs, or active bleeding that would make the subject unsuitable or unable to participate in the study
  • Concurrent chemotherapy or biological therapy. Concurrent radiotherapy is allowed as long as it is not the same site as the injected lesion.
  • Uncontrolled hepatitis B, hepatitis C, or HIV infection
  • History of organ allograft transplantation