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Can a vaccine plus a Blood-Vessel blocker stop airway growths from coming back?

NCT ID NCT07756840

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Sep 21, 2026 · Updated 28 times

Summary

This phase II trial tests whether combining bevacizumab, a drug that limits blood vessel growth, with PRGN-2012, a vaccine-based therapy, can help adults with recurrent respiratory papillomatosis (RRP) avoid needing more surgeries. RRP causes wart-like growths in the airway that can affect breathing and voice. Participants receive both treatments over about six months and are followed for a year to see if the growths stay away without further intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of two treatments: bevacizumab (a drug that blocks blood vessel growth) and PRGN-2012 (a vaccine-based therapy that targets HPV).
What this could lead to
If successful, this combination could reduce or eliminate the need for repeated surgeries in people with recurrent respiratory papillomatosis, potentially improving breathing and voice function.
What could go wrong
This is a phase II trial with a modest number of participants, so results may not generalize. The combination may cause side effects, and the vaccine component may not work in all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.