Respiratory PapillomatosisPhase 1/2NCT04398433
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
A Phase 1/2 study testing INO-3107 and CELLECTRA® 2000 in people with Respiratory Papillomatosis, run by Inovio Pharmaceuticals at 11 sites in United States.
Trial summary
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (HPV-11)-associated recurrent respiratory papillomatosis (RRP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Papillomatosis
- What is being tested?
- INO-3107 and CELLECTRA® 2000
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesUnited States
- Study dates
- 7 Oct 2020to 15 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Winship at Emory University Hospital Midtown
Atlanta, Georgia, 30308
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
UT Southwestern Medical Center
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas, 77005
NYU Langone Voice Center
New York, New York, 10016
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of California at Davis
Sacramento, California, 95817
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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)
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (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.
- Conditions
- Respiratory Papillomatosis
- Being tested
- INO-3107, CELLECTRA® 2000
- Keywords
- Human papilloma virus (HPV)
- Medical subject headings
- Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-3107Drug
INO-3107 administered by IM injection.
CELLECTRA® 2000Device
CELLECTRA® 2000 device used for EP following IM delivery of INO-3107.
| Study group | Role | What they receive |
|---|---|---|
| INO-3107: Group 1 | Experimental | Participants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. Receives: Drug: INO-3107; Device: CELLECTRA® 2000 |
| INO-3107: Group 2 | Experimental | Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. Receives: Drug: INO-3107; Device: CELLECTRA® 2000 |
| INO-3107: Group 3 | Experimental | Participants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. Receives: Drug: INO-3107; Device: CELLECTRA® 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.
Measured: From first dose of study drug through 30 days following the last dose (approximately up to Week 13)
Secondary outcomes (6)
Change in Number of Recurrent Respiratory Papillomatosis (RRP) Surgical Interventions in One Year Following Day 0, Compared to One Year Prior to Day 0
Measured: Up to Week 52
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
Measured: Up to Week 52
Change From Baseline in RRP Staging Assessment Scores Over Time
RRP staging assessment score was determined using a modified Derkay staging tool. It included both a subjective functional assessment of clinical parameters and an anatomic assessment of disease distribution. The anatomic score was then used in combination with the functional score to measure an individual participant's clinical course and response to the therapy over time. The score ranges from 0-179, where a higher score indicates worse disease. Baseline is defined as the most recent measurement prior to the first (Day 0) dose. Total Site Score + Total Symptom Score = Total Clinical Score.
Measured: Baseline, Weeks 6, 11, 26, and 52
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
Whole blood samples were collected and PBMCs were isolated to be tested for T-lymphocytes producing interferon-gamma (IFN-γ) in response to the human papilloma virus (HPV) types 6E6+6E7, and 11E6+11E7 antigens. The antigen-specific cellular immune response to INO-3107 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10^6, PBMC) using ELISpot for this outcome measure (OM).
Measured: Baseline, Weeks 6, 9, 11, 26, and 52
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
Cellular immune activity was measured using flow cytometry for the purposes of performing a lytic granule loading assay, which analyzed the intracellular markers involved in lytic degranulation and cytotoxic potential: Granzyme A (GrzA), Granzyme B (GrzB), Granulysin, and Perforin (Prf). Subtypes of CD8 T-cells: CD8 HPV-6 CD38+GrzA+GrzB+Prf+, CD8 HPV-11 CD38+GrzA+GrzB+Prf+, CD8 HPV-6 Ki67+GrzA+GrzB+Prf+, and CD8 HPV-11 Ki67+GrzA+GrzB+Prf+, subtypes of CD4 T-cells - CD4 HPV-6 CD38+, CD4 HPV-11 CD38+, CD4 HPV-6 Ki67+, and CD4 HPV-11 Ki67+ are reported.
Measured: Baseline, Weeks 6, 9, 11, 26, and 52
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
Pro-inflammatory elements:granulysin (GNLY),C-X-C motif chemokine receptor 6(CXCR6),C-C motif chemokine receptor 5(CCR5),CXCR3, granzyme A(GZMA),interferon regulatory factor1(IRF1),integrin subunit alpha 1(ITGA1),lymphocyte-specific protein tyrosine kinase(LCK),natural killer cell granule protein 7(NKG7),perforin-1(PRF1),eomesodermin(EOMES),CD3 delta subunit of T cell receptor complex(CD3D),CD3 epsilon subunit of T cell receptor complex(CD3E),\&CD8 subunit alpha(CD8A) in papilloma tissues are reported. Reads that mapped to transcript of each gene were counted to measure expression levels for genes from each sample. Raw counts per gene were generated. Counts per million (CPM) mapped reads were calculated \& globally normalized across samples using trimmed mean of M values (TMM).
Measured: Baseline, up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start7 Oct 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Skolnik, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398433
- Sponsor's protocol ID
- RRP-001
- Status last verified
- Mar 2026
- First submitted
- 14 May 2020
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Publications
Mau T, Amin MR, Belafsky PC, Best SR, Friedman AD, Klein AM, Lott DG, Paniello RC, Pransky SM, Saba NF, Howard T, Dallas M, Patel A, Morrow MP, Skolnik JM. Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis. Laryngoscope. 2023 Nov;133(11):3087-3093. doi: 10.1002/lary.30749. Epub 2023 May 19.
PubMed 37204106
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04398433
- Acronym / sponsor ID
- RRP-001
- Conditions
- Respiratory Papillomatosis
- Keywords
- Human papilloma virus (HPV)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INO-3107: Group 1 | Experimental | Drug: INO-3107, Device: CELLECTRA® 2000Participants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
| INO-3107: Group 2 | Experimental | Drug: INO-3107, Device: CELLECTRA® 2000Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
| INO-3107: Group 3 | Experimental | Drug: INO-3107, Device: CELLECTRA® 2000Participants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INO-3107INO-3107 administered by IM injection. | Drug | INO-3107: Group 1, INO-3107: Group 2, INO-3107: Group 3 |
| CELLECTRA® 2000CELLECTRA® 2000 device used for EP following IM delivery of INO-3107. | Device | INO-3107: Group 1, INO-3107: Group 2, INO-3107: Group 3 |
Primary outcome
Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From first dose of study drug through 30 days following the last dose (approximately up to Week 13)
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.
6 secondary outcomes
Change in Number of Recurrent Respiratory Papillomatosis (RRP) Surgical Interventions in One Year Following Day 0, Compared to One Year Prior to Day 0
Time frame: Up to Week 52
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
Time frame: Up to Week 52
Change From Baseline in RRP Staging Assessment Scores Over Time
Time frame: Baseline, Weeks 6, 11, 26, and 52
Change 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, and 52
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
Time frame: Baseline, Weeks 6, 9, 11, 26, and 52
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
Time frame: Baseline, up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37204106Mau T, Amin MR, Belafsky PC, Best SR, Friedman AD, Klein AM, Lott DG, Paniello RC, Pransky SM, Saba NF, Howard T, Dallas M, Patel A, Morrow MP, Skolnik JM. Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis. Laryngoscope. 2023 Nov;133(11):3087-3093. doi: 10.1002/lary.30749. Epub 2023 May 19.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Skolnik, MD study director
Inovio Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INO-3107 and CELLECTRA® 2000 in people with Respiratory Papillomatosis, run by Inovio Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs (time frame: From first dose of study drug through 30 days following the last dose (approximately up to Week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.