Description
Inclusion Criteria:
- * Age \>= 18 years old.
- * Histologically confirmed diagnosis of RRP.
- * Participants must require procedure(s) to remove papillomatous disease per standard of care.
- * A history of 2 or more surgeries within 12 months prior to treatment initiation in order to control laryngeal and/or tracheal RRP.
- * At least one of the following:
- * A Derkay score of 8 or greater
- * Measurable disease per RECIST 1.1 (participants with pulmonary RRP only)
- * Tracheostomy.
- * ECOG performance status of 0-1.
- * Participants must have adequate organ and marrow function as defined below:
- * White blood cells (WBC): \>2,000/microL
- * Absolute neutrophil count (ANC): \>=1,500/microL
- * Hemoglobin: \>9.0 g/dL
- * Platelets: \>=100,000/microL
- * Total bilirubin: \<=1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL
- * Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT): \<=2.5 X institutional upper limit of normal (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. In 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
- * Participants must have received their last systemic therapy for RRP \> 4 weeks or 5 half-lives, whichever is longer, prior to treatment initiation, except for systemic bevacizumab which must be \> 1 year prior to treatment initiation
- * Women of child-bearing potential (WOCBP) and men must agree to use highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization ) for the duration of bevacizumab treatment and up to 6 months after completion of bevacizumab treatment. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the participant is also acceptable.
- * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after bevacizumab treatment discontinuation.
- * All participants must have the ability to understand and willingness to sign a written informed consent.
- * All participants must be willing to undergo mandatory biopsy during the study.
Exclusion Criteria:
- -History of significant (i.e., active) cardiovascular disease or thromboembolic event:
- cerebral vascular accident/stroke (within 6 months prior to treatment initiation), myocardial infarction (within 6 months prior to treatment initiation), unstable angina, congestive heart failure (\>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication as assessed by EKG.
- * History of abdominal fistula or gastrointestinal perforation within 6 months prior to treatment initiation.
- * Major surgery within 4 weeks prior to treatment initiation.
- * Non-healing wound, active ulcer, or untreated bone fracture.
- * History of hemoptysis (\>2.5 mL of bright red blood per episode) within 1 month prior to 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 treatment initiation.
- * Inadequately controlled hypertension (defined as systolic blood pressure (BP) \>150 mmHg and/or diastolic blood pressure \> 100 mmHg), an average of 3 BP readings on 2 sessions will be used to measure blood pressure if initial reading indicates inadequately controlled hypertension. NOTE: 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 Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. NOTE: alopecia, sensory neuropathy Grade \<=2 are acceptable.
- * Known active alcohol or drug abuse.
- * History of allergy to study drug components.
- * Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in WOCBP performed at screening).
- * Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.
Ages Eligible for Study:
18 Years to 120 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No