Clinical trial · Interventional
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
A Phase II Study of Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths called papillomas to grow in the airway, most often in the voice box, windpipe, or lungs. These growths can make it hard to speak or breathe. Surgery can remove the papillomas, but they often come back. In some cases, they can become cancerous. Objective: This study istesting whether two treatments used together (PRGN-2012, a vaccine-based treatment and bevacizumab, a drug that affects blood vessel growth) can help control RRP and reduce the chance that papillomas will grow back. Eligibility: Adults aged 18 years and older may be able to join the study if they have RRP and meet certain treatment history requirements. This may include people who have previously received PRGN-2012 or bevacizumab, or people who have needed more than 2 surgeries to remove papillomas. Design: Before starting treatment, participants will have screening tests to make sure the study is safe for them. These tests may include a physical exam with blood and urine tests, heart function testing, imaging scans, and an endoscopy. During an endoscopy, a thin, flexible tube with a small camera will look at the inside of the nose, throat, voice box, and upper windpipe. Participants will receive study treatment during 7 clinic visits over about 6 months. Bevacizumab is given through a vein amd PRGEN-2012 is given as an injection under the skin of the arm or leg. Participants may receive 1 or both drugs at each visit. After completing treatmen, participants will return for 4 follow-up visits over 1 year. These visits may include repeat imaging, blood and urine tests, and other exams. After that, the study team will contact participantsby phone or email every 3 months for 2 years. If their RRP gets worse during the follow-up period, they may be able to receive a second course of treatment using the same schedule....
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus (HPV) | — | UNRESOLVED | — |
| Laryngeal Diseases | — | UNRESOLVED | — |
| Papillomavirus Infection | — | UNRESOLVED | — |
| Respiratory Recurrent Papillomatosis (RRP) | — | UNRESOLVED | — |
| Respiratory Tract Neoplasm | Respiratory System Neoplasm | ALIAS | 0.90 |
| Tracheal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| PRGN-2012 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Participants with RRP will be given Bevacizumab and PRGN-2012
- interventionNames
- Drug: PRGN-2012
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- To determine the complete response rate, defined as the percentage of participants who do not require an intervention (either medical or surgical) in the 12 months following completion of treatment with combination systemic bevacizumab and PRGN-...
- timeFrame
- From baseline to 12 months after treatment
- description
- Determined by measuring the number of participants (evaluable for clinical response) who do not require an intervention (either medical or surgical) in the 12 months following completion of treatment. This fraction of participants who are classified as having a complete response at 12 months will be reported along with 80% and 95% two-sided confidence intervals. For participants receiving re-treatment, any increase in their treatment-free interval following re-treatment will not be used for evaluation of the primary endpoint.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Histological or cytological diagnosis of RRP confirmed by pathology report. Note: If there is no documentation or archival sample, a biopsy will be done to confirm the diagnosis. * Age \>= 18 years old. * A history of 2 or more surgeries or use of IV bevacizumab in order to control laryngeal and/or tracheal RRP within 12 months prior to the study treatment initiation. * Previous treatment with PRGN-2012 (zopapogene imadenovec \[Papzimeos\]). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participants must have an adequate organ and marrow function as defined below: * White blood cells (WBC) \>2,000/mcL * Absolute neutrophil count (ANC) \>= 1,000/mcL * Hemoglobin \> 9.0 g/dL * Platelets \>= 100,000/mcL * Total bilirubin \<= 1.5 mg/dL. Note: participants with Gilbert s Syndrome must have a total bilirubin \< 3.0 mg/dL * Aspartate aminotransferase (AST) \<= 2.5 X institutional upper limit of normal (ULN) * Alanine aminotransferase (ALT) \<=2.5 X institutional ULN * Creatinine within normal institutional limits OR Creatinine Clearance (CrCl) \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal (calculated using the Cockcroft-Gault formula). * Prothrombin time (PT) / International normalized ratio (INR) and Partial thromboplastin time (PTT) \<= 1 X institutional ULN. In participants on anticoagulation, coagulation tests should be within a therapeutic range. * Urinalysis Urine dipstick \< 2+ proteinuria. Participants with \>= 2+ proteinuria on dipstick urinalysis should undergo a 24- hour urine collection and must demonstrate \<= 1g of protein in 24 hours to be eligible * Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of treatment and up to 6 months after completion of the study treatment. Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of treatment and up to 4 months after the last dose of study drugs. We also recommend men with partners of childbearing potential ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men must not freeze or donate sperm within the same period. * Women who are breastfeeding or plan to breastfeed must agree to discontinue breastfeeding from study treatment initiation. * Ability of participant to understand and sign a written informed consent document. EXCLUSION CRITERIA: * History of significant cardiovascular disease or thromboembolic event: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (\>= New York Heart Association Classification Class II) occurring within 12 months prior to the study treatment initiation * Serious cardiac arrhythmia requiring medication as assessed by electrocardiogram (EKG) at screening. * Any investigational agents within 4 weeks prior to the study treatment initiation. * Systemic medical RRP therapy within 4 weeks or 3 half-lives, whichever is longer prior to the study treatment initiation. * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the study treatment initiation. Note: Inhaled, topical intranasal or intraocular steroids, and adrenal replacement doses \<10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * History of abdominal fistula or gastrointestinal perforation within 12 months prior to the study treatment initiation. * Major surgery within 4 weeks prior to the study treatment initiation. Note: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges). * Non-healing wounds, active ulcer, or untreated bone fracture. * History of hemoptysis (\>2.5 mL of bright red blood per episode) within 1 month prior to the study treatment initiation. * History of serious hemorrhage (CTCAE Grade 4) within 12 months prior to the study treatment initiation. * Evidence of bleeding diathesis or significant coagulopathy (with or without current therapeutic anticoagulation). * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the study treatment initiation. * Inadequately controlled hypertension (defined as systolic blood pressure (BP) \>150 mmHg and/or diastolic blood pressure \> 100 mmHg). Note: an average of 3 BP readings on 2 sessions will be used to measure blood pressure if the initial reading indicates inadequately controlled hypertension. Anti-hypertensive therapy to achieve blood pressures below these parameters is allowed. * Prior history of hypertensive crisis or hypertensive encephalopathy. * Persisting toxicity related to prior therapy of Grade \>1 per CTCAE. Note: Alopecia, sensory neuropathy Grade \<= 2 are acceptable. * Known, active alcohol or drug abuse. * History of allergy to study drug components. * History of \>= Grade 3 per CTCAE infusion-related reaction to bevacizumab or PRGN-2012. * Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening. * Uncontrolled symptomatic, intercurrent illness evaluated by medical history, physical exam, and labs, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study, or that would limit compliance with study requirements.
References
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