Respiratory Tract DiseasesPhase 2NCT05797246
Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
A Phase 2 study testing Bevacizumab in people with Respiratory Tract Diseases and Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Respiratory Tract Diseases, Neoplasms, Neoplasms by Histologic Type
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old.
- Histologically confirmed diagnosis of RRP.
- Individuals must require procedure(s) to remove papillomatous disease per standard of care.(not required for re-treatment)
- A history of 2 or more surgeries within 12 months prior to treatment initiation in order to control laryngeal and/or tracheal RRP (not required for re-treatment).
- At least one of the following (not required for re-treatment):
- A Derkay score of 8 or greater
Show all 27Show fewer
- Measurable disease per RECIST 1.1 (participants with pulmonary RRP only)
- Tracheal involvement with RRP that has required two or more clinical interventions in the last 12 months (two or more clinical interventions)
- Tracheostomy.
- ECOG performance status of 0-1.
- Individuals 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
- Individuals 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 (not applicable for re-treatment)
- Individuals able to become pregnant and their partners 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 individual is also acceptable.
- Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 6 months after bevacizumab treatment discontinuation.
- All individuals must have the ability to understand and willingness to sign a written informed consent.
- All individuals must be willing to undergo mandatory biopsy during the study (not applicable for re-treatment).
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study of Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed.
Read more
Objective:
To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP.
Eligibility:
People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways.
Design:
Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest.
Participants will have surgery to remove the growths in their airways.
Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours.
Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia.
Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle.
Follow-up will continue for 1 year after the last treatment.
Read the detailed description
Background:
- Recurrent respiratory papillomatosis (RRP) is a rare papillomatous disease of the respiratory tract that is caused by Human Papilloma Virus (HPV) types 6 or 11.
- RRP can progress to cause severe voice disturbance, airway compromise, fatal pulmonary lesions, and rarely invasive cancers.
- There is no approved systemic therapy for RRP. Participants require repeated surgical procedures for disease debridement and control.
- Translational research studies have shown high levels of vascularity in papilloma tissue driven in part by high levels of vascular endothelial growth factor (VEGF)-A mRNA, vascular endothelial growth factor receptors (VEGFR)-1 and VEGFR-2 and elevated serum levels of VEGF-A, particularly in cases of aggressive RRP.
- Papillomas are also infiltrated by immunosuppressive myeloid and regulatory T-cells.
- Systemic inhibition of VEGF signaling may reduce VEGF-driven angiogenesis in papillomas and reduce chemotaxis and expansion of immunosuppressive myeloid cells and regulatory T-cells.
- Bevacizumab is a recombinant humanized monoclonal antibody that binds all active forms of VEGF-A.
- Bevacizumab is FDA approved for the treatment of metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, recurrent glioblastoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer and was selected for its demonstrated activity in a variety of cancers and for its acceptable safety profile.
- Use of systemic bevacizumab in patients with severe and/or tracheal RRP has not been studied prospectively in controlled clinical studies, but clinical safety and activity has been reported in retrospective single institution case series.
- Bevacizumab resistance can develop in cancer patients due to a variety of tumor escape mechanisms that are unlikely to occur in RRP patients with normal endothelial cells, but bevacizumab re-treatment for recurrent RRP has not been evaluated in controlled clinical studies.
Objective:
-To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab
Eligibility:
- Histologically confirmed diagnosis of RRP
- A history of 2 or more surgeries in the last 12 months in order to control laryngeal and/or tracheal RRP
- At least one of the following:
- A Derkay score of 8 or greater
- Pulmonary RRP with disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Tracheal involvement with RRP that has required two or more clinical interventions in the last 12 months
- Tracheostomy
- Age >=18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Design:
- This is a phase II, single arm clinical trial evaluating systemic bevacizumab.
- Participants will receive bevacizumab (10 mg/kg IV) every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.
- Operative examination under anesthesia (EUA) with biopsies for research and possible papilloma debulking for safety will be performed before dose 1, optional EUA for research biopsies may be performed following dose 2 and at cycles 6 and 11.
- Participants may undergo standard-of-care operative EUA with papilloma cleanout during the 1-year treatment period as clinically indicated at the NIH.
- The mean surgery-free interval during the 1-year treatment period will be compared to the mean surgery-free interval in the 12 months prior to treatment.
- Participants will also be assessed for papilloma recurrence and surgery-free interval at 6, 12, 24 weeks and every 3 months after that until 1 year following completion of treatment.
- A total of 20 evaluable participants will be treated on study.
- During the follow up period, up to 15 participants who develop sufficient papilloma recurrence to require a clinical intervention may be re-treated with 11 additional cycles of bevacizumab (10 mg/kg IV) following the same schedule as the initial treatment.
- Prior to the initiation of re-treatment, an optional operative EUA with biopsies for research and possible papilloma debulking for safety may be performed.
- Conditions
- Respiratory Tract Diseases, Neoplasms, Neoplasms by Histologic Type, Neoplasms, Glandular and Epithelial, Neoplasms, Squamous Cell, Tumor Virus Infections
- Being tested
- Bevacizumab
- Keywords
- Human Papilloma Virus, Dose Escalation, laryngotracheal disease, papillomatous disease
- Medical subject headings
- Respiratory Tract Diseases, Neoplasms, Neoplasms by Histologic Type, Neoplasms, Glandular and Epithelial, Neoplasms, Squamous Cell, Tumor Virus Infections, Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
10 mg/kg IV every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Bevacizumab treatment course Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab.
Determined by measuring the mean duration between successive clinically indicated surgeries in the 12 months during treatment for that participant and determining whether that duration is longer than the mean duration between successive clinically indicated surgeries in the 12 months prior to treatment by one month or more. This fraction of participants who are classified as having a success will be reported along with a 95% confidence interval.
Measured: 1 year
Secondary outcomes (4)
Rate of pulmonary RRP partial response (PR) and complete response (CR) by RECIST 1.1 in participants with pulmonary disease.
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.
Measured: 6 weeks after completion of treatment
Recurrence free interval after treatment
Time to recurrence of papillomatous disease after completion of treatment will be recorded and reported descriptively.
Measured: Weeks 6, 12, 24 and remote assessment (if needed)
The safety of systemic bevacizumab in participants with aggressive RRP
Evaluation of safety will be done as follows: each participant will be evaluated for safety and toxicity, and the fraction of participants experiencing AEs will be reported by type and grade of AE
Measured: 42 days after the study agent was last administered
The rate of papilloma regrowth by determining the percentage of participants with an increase in their surgery-free interval after treatment with systemic bevacizumab
The rate of papilloma regrowth will be determined by measuring the mean duration between successive clinically indicated surgeries in the 12 months after treatment for that participant and determining whether that duration is longer than the mean duration between successive clinically indicated surgeries in the 12 months prior to treatment by one month or more. This fraction of participants who are classified as having a success will be reported along with a 95% confidence interval.
Measured: Weeks 6, 12, 24 after completion of treatment, every 3 months after that with the last evaluation performed at 1 year after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start2 Aug 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott M Norberg, D.O., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797246
- Sponsor's protocol ID
- 10001572
- Other IDs
- 001572-C
- Status last verified
- 22 Jan 2026
- First submitted
- 1 Apr 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
- ClinicalTrials.gov ID
- NCT05797246
- Acronym / sponsor ID
- 10001572
- Conditions
- Respiratory Tract Diseases, Neoplasms, Neoplasms by Histologic Type, Neoplasms, Glandular and Epithelial, Neoplasms, Squamous Cell, Tumor Virus Infections
- Keywords
- Human Papilloma Virus, Dose Escalation, laryngotracheal disease, papillomatous disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed.
Objective:
To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP.
Eligibility:
People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways.
Design:
Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest.
Participants will have surgery to remove the growths in their airways.
Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours.
Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia.
Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle.
Follow-up will continue for 1 year after the last treatment.
Detailed description
Background:
- Recurrent respiratory papillomatosis (RRP) is a rare papillomatous disease of the respiratory tract that is caused by Human Papilloma Virus (HPV) types 6 or 11.
- RRP can progress to cause severe voice disturbance, airway compromise, fatal pulmonary lesions, and rarely invasive cancers.
- There is no approved systemic therapy for RRP. Participants require repeated surgical procedures for disease debridement and control.
- Translational research studies have shown high levels of vascularity in papilloma tissue driven in part by high levels of vascular endothelial growth factor (VEGF)-A mRNA, vascular endothelial growth factor receptors (VEGFR)-1 and VEGFR-2 and elevated serum levels of VEGF-A, particularly in cases of aggressive RRP.
- Papillomas are also infiltrated by immunosuppressive myeloid and regulatory T-cells.
- Systemic inhibition of VEGF signaling may reduce VEGF-driven angiogenesis in papillomas and reduce chemotaxis and expansion of immunosuppressive myeloid cells and regulatory T-cells.
- Bevacizumab is a recombinant humanized monoclonal antibody that binds all active forms of VEGF-A.
- Bevacizumab is FDA approved for the treatment of metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, recurrent glioblastoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer and was selected for its demonstrated activity in a variety of cancers and for its acceptable safety profile.
- Use of systemic bevacizumab in patients with severe and/or tracheal RRP has not been studied prospectively in controlled clinical studies, but clinical safety and activity has been reported in retrospective single institution case series.
- Bevacizumab resistance can develop in cancer patients due to a variety of tumor escape mechanisms that are unlikely to occur in RRP patients with normal endothelial cells, but bevacizumab re-treatment for recurrent RRP has not been evaluated in controlled clinical studies.
Objective:
-To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab
Eligibility:
- Histologically confirmed diagnosis of RRP
- A history of 2 or more surgeries in the last 12 months in order to control laryngeal and/or tracheal RRP
- At least one of the following:
- A Derkay score of 8 or greater
- Pulmonary RRP with disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Tracheal involvement with RRP that has required two or more clinical interventions in the last 12 months
- Tracheostomy
- Age >=18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Design:
- This is a phase II, single arm clinical trial evaluating systemic bevacizumab.
- Participants will receive bevacizumab (10 mg/kg IV) every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.
- Operative examination under anesthesia (EUA) with biopsies for research and possible papilloma debulking for safety will be performed before dose 1, optional EUA for research biopsies may be performed following dose 2 and at cycles 6 and 11.
- Participants may undergo standard-of-care operative EUA with papilloma cleanout during the 1-year treatment period as clinically indicated at the NIH.
- The mean surgery-free interval during the 1-year treatment period will be compared to the mean surgery-free interval in the 12 months prior to treatment.
- Participants will also be assessed for papilloma recurrence and surgery-free interval at 6, 12, 24 weeks and every 3 months after that until 1 year following completion of treatment.
- A total of 20 evaluable participants will be treated on study.
- During the follow up period, up to 15 participants who develop sufficient papilloma recurrence to require a clinical intervention may be re-treated with 11 additional cycles of bevacizumab (10 mg/kg IV) following the same schedule as the initial treatment.
- Prior to the initiation of re-treatment, an optional operative EUA with biopsies for research and possible papilloma debulking for safety may be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BevacizumabBevacizumab treatment course |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age >= 18 years old.
- Histologically confirmed diagnosis of RRP.
- Individuals must require procedure(s) to remove papillomatous disease per standard of care.(not required for re-treatment)
- A history of 2 or more surgeries within 12 months prior to treatment initiation in order to control laryngeal and/or tracheal RRP (not required for re-treatment).
- At least one of the following (not required for re-treatment):
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Bevacizumab10 mg/kg IV every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total. | Drug | Arm 1 |
Primary outcome
To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab.
Time frame: 1 year
Determined by measuring the mean duration between successive clinically indicated surgeries in the 12 months during treatment for that participant and determining whether that duration is longer than the mean duration between successive clinically indicated surgeries in the 12 months prior to treatment by one month or more. This fraction of participants who are classified as having a success will be reported along with a 95% confidence interval.
4 secondary outcomes
Rate of pulmonary RRP partial response (PR) and complete response (CR) by RECIST 1.1 in participants with pulmonary disease.
Time frame: 6 weeks after completion of treatment
Recurrence free interval after treatment
Time frame: Weeks 6, 12, 24 and remote assessment (if needed)
The safety of systemic bevacizumab in participants with aggressive RRP
Time frame: 42 days after the study agent was last administered
The rate of papilloma regrowth by determining the percentage of participants with an increase in their surgery-free interval after treatment with systemic bevacizumab
Time frame: Weeks 6, 12, 24 after completion of treatment, every 3 months after that with the last evaluation performed at 1 year after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared.
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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.
Scott M Norberg, D.O. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Respiratory Tract Diseases and Neoplasms, run by National Cancer Institute (NCI) at 1 site 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 27 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.