Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
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|ClinicalTrials.gov Identifier: NCT04724980|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Recurrent Respiratory Papillomatosis Papillomavirus Infections Papillomaviridae||Drug: PRGN-2012||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis|
|Actual Study Start Date :||March 16, 2021|
|Estimated Primary Completion Date :||March 20, 2024|
|Estimated Study Completion Date :||March 20, 2024|
Experimental: Adjuvant PRGN-2012
Four PRGN-2012 administrations (on days 1, 15, 43, and 85) via subcutaneous injection.
In the Phase I, 3+3 dose escalation clinical trial evaluating PRGN-2012 at two dose levels (1x10^11 and 5x10^11 particle units (PU)) administered as adjuvant therapy prior to standard-of-care debulking surgery.
In the Phase II segment, PRGN-2012 is evaluated at the RP2D.
- Determine the percentage of patients with an increase in their surgery-free interval (SFI) following adjuvant treatment with PRGN-2012 [ Time Frame: 12 months ]Measuring the mean duration between successive clinically-indicated surgeries in the 12 months after treatment for that patient and determining whether that duration is longer than the mean duration between successive clinically-indicated surgeries in the 12 months prior to treatment. This fraction of patients who are classified as having a success will be reported along with a 95% confidence interval.
- Determine the incidence of dose limiting toxicities to evaluate safety and identify recommended Phase II adjuvant dosing (RP2D) of PRGN-2012 [ Time Frame: 28 days ]The incidence of dose limiting toxicities experienced by patients at each dose level will be reported per dose level and maximum tolerated dose will be the RP2D. The grade as well as the type of toxicity will be tabulated per dose level to evaluate safety.
- Time to recurrence of papillomatous disease after completion of treatment will be recorded [ Time Frame: 1 year ]Time to recurrence of papillomatous disease after completion of treatment will be recorded. The frequency of surgery in the 12 months before or after treatment will be assessed across all treated patients for a statistically significant difference using Wilcoxon matched-pairs analysis.
- Rate of pulmonary RRP partial response in participants with pulmonary disease [ Time Frame: 1 year ]The fraction of participants with a pulmonary RRP partial response and a pulmonary RRP complete response will be reported in all treated pulmonary participants, along with 95% confidence intervals for each.
- Frequency of debulking surgery during the 12 months pre and 12 months post treatment [ Time Frame: 1 year ]The frequency of surgery in the 12 months before or after treatment will be assessed across all treated patients for a statistically significant difference using Wilcoxon matched-pairs analysis.
- Rate of pulmonary RRP complete response in participants with pulmonary disease [ Time Frame: 1 year ]The fraction of participants with a pulmonary RRP partial response and a pulmonary RRP complete response will be reported in all treated pulmonary participants, along with 95% confidence intervals for each.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18 years and older
Clinical diagnosis of RRP
- Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified laboratory
- Presence of laryngotracheal papillomas with or without pulmonary RRP
- A history of 2 or more interventions in the last 12 months for control of RRP
- Clinical performance status of ECOG of 0-1
- Willing to undergo endoscopic evaluation and operative interventions with biopsies in compliance with this protocol
- No systemic therapy for RRP for at least 3 half-lives of the prior drug(s). A 30-day washout is required for systemic bevacizumab treatment
- Participants who have received prior immunotherapy for RRP are permitted
- Participants must have adequate organ and marrow function as defined below:
- Sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method throughout vaccine treatment and for at least 120 days after vaccine treatment. Highly effective methods are defined as: Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, and partner's vasectomy; other effective methods are defined as a latex condom, diaphragm, and cervical cap.
- Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (Hep B DNA quant, HBV viral load), and if confirmatory tests are negative, the participant can be enrolled.
- Seronegative for hepatitis C antibody unless antigen negative. If the hepatitis C antibody test is positive, then participants must be tested for the presence of antigen by Hep C RNA quant, HCV viral load, and be HCV RNA negative
- All participants must have the ability to understand and willingness to sign a written informed consent
- A history of surgical debridement of papillomas such that in the opinion of the study team a participant is unlikely to be able to safely have a six-week interval between surgical interventions.
- History of significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (greater than or equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Any severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, liver disease, lung disease (with the exception of what is specified in the inclusion criteria) , or laboratory abnormalities that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study. Participants with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) well controlled with oral or inhaled medications are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled, topical intranasal or intro-ocular steroids, and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Participants who are receiving any other investigational agents
- Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 5.0; however, alopecia, sensory neuropathy Grade less than or equal to 2 or other Grade less than or equal to 2 AEs not constituting a safety risk based on investigator's judgment are acceptable.
- Known alcohol or drug abuse.
- Participant, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- History of allergy to study drug components.
- Pregnant women are excluded from this study because PRGN-2012 is an agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PRGN-2012, breastfeeding should be discontinued if the mother is treated with PRGN-2012. These potential risks may also apply to other agents used in this study.
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): NCT04724980
|Contact: Amy Lankford, PhDemail@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Study Director:||Amy Lankford, PhD||Precigen, Inc|
|Responsible Party:||Precigen, Inc|
|Other Study ID Numbers:||
|First Posted:||January 26, 2021 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
|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|
Human Papilloma Virus
Respiratory Tract Infections
DNA Virus Infections
Tumor Virus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases