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INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

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. Read our disclaimer for details. Identifier: NCT04398433
Recruitment Status : Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : May 18, 2023
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in subjects with HPV-6 and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis <12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.

Condition or disease Intervention/treatment Phase
Respiratory Papillomatosis Drug: INO-3107 Device: CELLECTRA™ 2000 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multi-center Study of INO-3107 With Electroporation (EP) in Subjects With HPV-6- and/or HPV-11-associated Recurrent Respiratory Papillomatosis (RRP)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: INO-3107
Participants will be administered one INO-3107 intramuscular (IM) injection followed by electroporation (EP) using CELLECTRA™ 2000 at Day 0, Week 3, Week 6, and Week 9.
Drug: INO-3107
INO-3107 administered by IM injection followed by EP using CELLECTRA™ 2000 device at Day 0, Week 3, 6, and 9.

Device: CELLECTRA™ 2000
CELLECTRA™ 2000 device used for EP following IM delivery of INO-3107.

Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to Week 52 (up to approximately 1 year) ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1. Results in death. 2. A life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Results in a congenital anomaly/birth.

Secondary Outcome Measures :
  1. The Number of RRP Surgical Interventions in the 52 Weeks Post Day 0 Compared to the Number of RRP Surgical Interventions in the Year Prior to Day 0 Dosing [ Time Frame: Screening up to Week 52 (up to approximately 1 year) ]
  2. Change in RRP Staging Assessment Scores Over Time [ Time Frame: Screening, Day 0, Weeks 6, 11, 26, 52 (up to approximately 1 year) ]
    An RRP Staging Assessment score will be determined using a modified Derkay staging tool. It includes both a subjective functional assessment of clinical parameters and an anatomic assessment of disease distribution. The anatomic score can then be used in combination with the functional score to measure an individual patient's clinical course and response to the therapy over time.

  3. Change from Baseline in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs) [ Time Frame: Baseline, Weeks 6, 9, 11, 26, 52 ]
  4. Change from Baseline in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs [ Time Frame: Baseline, Weeks 6, 9, 11, 26, 52 ]
  5. Change from Baseline in Resected Tumor Tissue Response Magnitude for Pro-inflammatory and Immunosuppressive Elements [ Time Frame: Baseline and at subsequent tissue resections, up to Week 52 (up to approximately 1 year) ]
  6. Change from Baseline in MicroRNA (miRNA) Expression Related to Reduced Frequency of RRP Surgical Intervention [ Time Frame: Baseline and Week 6 ]

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.

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

Key Inclusion Criteria:

  • Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma or documentation of low-risk positive HPV using a Sponsor approved HPV-6/11 type-specific assay
  • Requirement for frequent RRP intervention to remove or resect respiratory papilloma, as defined as at least two RRP surgical (including laser) interventions in the year prior to and including Day 0
  • Must be an appropriate candidate for upcoming surgical intervention as per Investigator judgment and RRP Staging Assessment score
  • Adequate bone marrow, hepatic, and renal function
  • Participants must meet one of the below requirements:

    • Be of non-child bearing potential (≥12 months of non-therapy-induced amenorrhea, confirmed by follicle-stimulating hormone [FSH], if not on hormone replacement)
    • Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females)
    • Agree to use one highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and at least through week 12 after last dose
    • Agree to abstinence from penile-vaginal intercourse, when this is the participant's preferred and usual lifestyle

Key Exclusion Criteria:

  • Recipient of therapy directed towards RRP disease (other than surgery or ablation) including but not limited to anti-virals (including cidofovir), radiation, chemotherapy, anti-angiogenic therapy (including bevacizumab), prophylactic HPV vaccination (including Gardasil) as therapeutic intervention, or therapy with an experimental agent within 3 months prior to Day 0
  • Ongoing or recent (within 1 year) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments, with the exception of: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment
  • Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, including systemic corticosteroids
  • High risk of bleeding or require the use of anticoagulants for management of a known bleeding diathesis
  • Recipient of any live virus vaccine within 4 weeks prior to the first dose of trial treatment or any non-live vaccine within two weeks prior to the first dose of trial treatment
  • History of clinically significant, medically unstable disease which, in the judgment of the Investigator, would jeopardize the safety of the participant, interfere with trial assessment or evaluation, or otherwise impact the validity of the trial results
  • Fewer than two acceptable sites are available for IM injection considering the deltoid and anterolateral quadriceps muscles. Study treatment should not be given within 2 centimeters (cm) of a tattoo, keloid or hypertrophic scar. If there is implanted metal, implanted device, within the same limb the use of the deltoid muscle on the same side of the body is excluded
  • Prisoners or participants who are compulsory detained (involuntary incarceration) for treatment of either a psychiatric or physical (i.e. infectious disease) illness
  • Any medical or psychological or non-medical condition that might interfere with the participation or safety of the participant, as determined by the investigator

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): NCT04398433

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United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
University of California at Davis
Sacramento, California, United States, 95817
United States, Georgia
Winship at Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Voice Center
New York, New York, United States, 10016
United States, North Carolina
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77005
Sponsors and Collaborators
Inovio Pharmaceuticals
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Study Director: Jeffrey Skolnik, MD Inovio Pharmaceuticals
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Responsible Party: Inovio Pharmaceuticals Identifier: NCT04398433    
Other Study ID Numbers: RRP-001
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

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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
Keywords provided by Inovio Pharmaceuticals:
Human papilloma virus (HPV)
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Genital Diseases
Urogenital Diseases
Disease Attributes
Pathologic Processes