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

  • STATUS
    Recruiting
  • participants needed
    63
  • sponsor
    Inovio Pharmaceuticals
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Updated on 5 August 2020
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renal function
vasectomy
papillomatosis
recurrent respiratory papillomatosis
respiratory papilloma

Summary

This is an open-label phase1/2, multi-center trial to evaluate the efficacy, safety, tolerability and immunogenicity of INO-3107 in participants with HPV-6 and/or HPV-11 associated recurrent respiratory papillomatosis (RRP). The trial population is divided into two cohorts: Cohort A: Participants with diagnoses of Juvenile-Onset RRP as defined by age at first diagnosis of RRP < 12 years. Cohort B: Participants with Adult-onset RRP as defined by age at first diagnosis of RRP 12 years. A safety run-in will be performed with up to six participants across cohort A and B with a one week waiting period between each enrolled participant.

Details
Condition Respiratory Papillomatosis
Age 18years - 100years
Treatment INO-3107, CELLECTRA™ 2000
Clinical Study IdentifierNCT04398433
SponsorInovio Pharmaceuticals
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma
Requirement for frequent surgical intervention to remove or resect respiratory papilloma, as defined by at least 2 interventions per year for three years prior to Day 0; participants must have a history of at least two surgical procedures during the third year prior to their screening date and during the second year prior to their screening date and at least one surgical procedure with a requirement of a future surgical procedure during the year prior to their screening date
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
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

Exclusion Criteria

Recipient of therapy directed towards HPV disease (other than surgery or ablation) including but not limited to anti-virals (including cidofovir), radiation, chemotherapy, anti-angiogenic therapy (including bevacizumab), therapeutic vaccination (including Gardasil), or therapy with an experimental agent within 6 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
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
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