ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 10 for:    morphogenesis
Previous Study | Return to List | Next Study

pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma

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: NCT03655756
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
Morphogenesis, Inc.

Brief Summary:
Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business days for any delayed adverse events.

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma, Stage III Cutaneous Melanoma, Stage IV Biological: IFx-Hu2.0 Early Phase 1

Detailed Description:

Six male and/or female adult patients (greater than or equal to 18 years old), of any ethnicity and race, with unresectable stage III or stage IV cutaneous melanoma with accessible lesions, will be eligible for enrollment and treatment with IFx-Hu2.0.

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. Talimogene laherparepvec (IMLYGIC®) is indicated for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Therefore, 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.

Enrollees will receive IFx-Hu2.0 at a single time point. Depending on the number of accessible lesions, a patient could receive up to three doses across three lesions (one dose per lesion). Forty milliliters of peripheral blood will be collected from these patients prior to treatment administration and at the follow-up visit four weeks later. The target dose will be 100 μg of plasmid DNA per lesion injected at a final dose volume of 200 μL per lesion. To allow for the observation of any acute toxicity in the first subject enrolled and prevent any occurrence of excessive toxicities in subsequent subjects, the first subject enrolled will receive a single dose of IFx-Hu2.0. Subsequent subjects will be administered the product after at least seven days. Beyond the first subject, the maximum number of lesions to be injected at any given time point in the study phase proposed is three lesions. These samples will be used to perform complete blood counts (CBC) and clinical chemistry tests. A urine sample will be obtained for urinalysis for protein and blood at the same frequency. Blood samples will be drawn for immune response evaluation as well. At the end of the study period, a biopsy of the lesion injected and a non-injected lesion (if applicable) will be collected. If the patient has a response to therapy, the patient will have the option of continuing the study at three-week intervals so long as they have not progressed. Optional tumor biopsies and peripheral blood collections may be obtained on subsequent treatment cycles.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients With Unresectable Stage III or Stage IV Cutaneous Melanoma
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma


Intervention Details:
  • Biological: IFx-Hu2.0

    The product being tested in this clinical study, IFx-Hu2.0, is designed to exploit the inherent vulnerability of specific differences from patient to patient, lesion to lesion, and cell to cell. Regardless of the degree of complexity of an individual's antigenic signature, this truly patient-specific approach capitalizes on the antigenic differences to create the broadest immune response possible.

    Surface expression of the Emm55 antigen through intralesional injection of pAc/emm55 engages the patient's immune system and thwarts the tumor's ability to evade surveillance by exposing multiple patient-specific tumor antigens and activating a wide array of naïve T cells.

    Other Name: pDNA encoding a Streptococcal antigen in a polymer solution


Primary Outcome Measures :
  1. Safety; defined as four of the six patients enrolled having no grade-3 or higher treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: 28 Days ]
  2. Feasibility; defined as the ability to treat at least five of the six patients enrolled without dose-limiting toxicity. [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) determined using standard criteria. [ Time Frame: 1 Year ]
    ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression.



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
Criteria

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.
  • Life expectancy of fewer than three months
  • 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

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): NCT03655756


Contacts
Contact: Michael JP Lawman, PhD 813-875-6600 ext 101 mlawman@morphogenesis-inc.com
Contact: Patricia D Lawman, PhD 813-875-6600 ext 102 plawman@morphogenesis-inc.com

Locations
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Joseph Markowitz, MD, PhD    813-745-4673    Joseph.Markowitz@moffitt.org   
Sponsors and Collaborators
Morphogenesis, Inc.
H. Lee Moffitt Cancer Center and Research Institute

Responsible Party: Morphogenesis, Inc.
ClinicalTrials.gov Identifier: NCT03655756     History of Changes
Other Study ID Numbers: CM 2017-01
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Morphogenesis, Inc.:
Unresectable
Melanoma
pDNA
Plasmid DNA
Gene Therapy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas