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Trial record 16 of 25 for:    recurrent respiratory papillomatosis

Avelumab for People With Recurrent Respiratory Papillomatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859454
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : May 14, 2019
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Scott Norberg, D.O., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Respiratory Papillomatosis
Juvenile Laryngeal Papilloma
Laryngeal Papilloma, Recurrent
Respiratory Papillomatosis
Human Papilloma Virus
Intervention Drug: Avelumab
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
PI discretion/off study prior to trtmt             1
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
46.95  (15.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
1
   7.7%
Not Hispanic or Latino
12
  92.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  15.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
  76.9%
More than one race
1
   7.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
Patients Who Had Repeated Endoscopic Debulking to Remove Paillomatosis Lesions Prior to Treatment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
13
 100.0%
[1]
Measure Description: All patients underwent multiple surgeries as part of standard of care treatment for Recurrent Respiratory Papillomatosis (RRP) prior to enrolling in this protocol.
1.Primary Outcome
Title Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy
Hide Description The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Complete response is assessed by The Derkay Staging System which is defined as a physical exam and/or clinic-based flexible nasopharyngolaryngoscopy and/or tracheoscopy, exam under anesthesia with endoscopy and biopsies; no evidence of papillomas on physical exam and/or clinic based flexible nasopharyngolaryngoscopy and/or tracheoscopy; and no evidence of papillomas by exam under anesthesia (sedation or general anesthesia) with endoscopy and biopsies.
Time Frame Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans
Hide Description Complete response is measured by The Response Criteria in Solid Tumors (RECIST) v1.1 calculated from chest CT scans. Complete response is absence of disease (e.g., lesions) by imaging.
Time Frame Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Hide Description The Voice Handicap Index-10 questionnaire (as measured by derkay score) consists of 10 questions and determines whether a participant has a voice handicap. The scoring options for each question range from 0 (for never) to 4 (for always). The total scores (combined value from all 10 questions) range from 0 - 40. Higher scores represent a worse voice handicap. Lower scores represent a less voice handicap.
Time Frame Baseline, 6 weeks, and 12 weeks after the first dose of Avelumab.
Hide Outcome Measure Data
Hide Analysis Population Description
Only one participant in each row contributed data in each row.
Arm/Group Title All Participants at Baseline All Participants at 6 Weeks All Participants at 12 Weeks
Hide Arm/Group Description:

All participants Voice Handicap Index-10 Score at Baseline.

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses. Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

All participants Voice Handicap Index-10 Score at 6 Weeks.

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

All participants Voice Handicap Index-10 Score at 12 Weeks.

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 12 12 12
Measure Type: Number
Unit of Measure: scores on a scale
Patient 1 Number Analyzed 1 participants 1 participants 1 participants
26 22 23
Patient 2 Number Analyzed 1 participants 1 participants 1 participants
9 12 3
Patient 3 Number Analyzed 1 participants 1 participants 1 participants
40 37 38
Patient 4 Number Analyzed 1 participants 1 participants 1 participants
17 16 16
Patient 5 Number Analyzed 1 participants 1 participants 1 participants
12 2 1
Patient 6 Number Analyzed 1 participants 1 participants 1 participants
19 0 0
Patient 7 Number Analyzed 1 participants 1 participants 1 participants
40 21 18
Patient 8 Number Analyzed 1 participants 1 participants 1 participants
30 35 29
Patient 9 Number Analyzed 1 participants 1 participants 1 participants
37 40 40
Patient 10 Number Analyzed 1 participants 1 participants 1 participants
18 11 12
Patient 11 Number Analyzed 1 participants 1 participants 1 participants
18 9 0
Patient 13 Number Analyzed 1 participants 1 participants 1 participants
18 19 15
4.Secondary Outcome
Title Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy
Hide Description Partial response is assessed by flexible nasopharyngolaryngoscopy and/or tracheoscopy using the Derkay staging system if the patient does not have pulmonary disease. The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Partial response is a decrease in Derkay anatomic score of 30% or greater.
Time Frame Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
6
  66.7%
5.Secondary Outcome
Title Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans
Hide Description Partial response assessed by imaging using RECIST v1.1. is defined as a ≥ 30% decrease in the sum of the longest diameters of target lesions compared with baseline.
Time Frame Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression, up to 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Duration of Clinical Responses to Avelumab
Hide Description The duration of clinical responses to Avelumab is calculated from the protocol end of treatment endoscopic debulking to the next clinically indicated endoscopic debulking procedure.
Time Frame Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 4.5 yrs
Hide Outcome Measure Data
Hide Analysis Population Description
5/12 participants were evaluable for this outcome measure.
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: Months
14.7
(4.5 to 51)
7.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 28 months and 20 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
13
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 28 months and 20 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.

All-Cause Mortality
Avelumab
Affected / at Risk (%)
Total   0/13 (0.00%)    
Hide Serious Adverse Events
Avelumab
Affected / at Risk (%) # Events
Total   2/13 (15.38%)    
Cardiac disorders   
Cardiac disorders - Other, Stress cardiomyopathy  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Diarrhea  1  1/13 (7.69%)  1
Ileus  1  1/13 (7.69%)  1
Small intestinal obstruction  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/13 (7.69%)  1
Vascular disorders   
Hypotension  1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Avelumab
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/13 (15.38%)  3
Cardiac disorders   
Cardiac disorders - Other, Stress cardiomyopathy  1  1/13 (7.69%)  1
Cardiac troponin I increased  1  1/13 (7.69%)  1
Ejection fraction decreased  1  1/13 (7.69%)  2
Sinus bradycardia  1  5/13 (38.46%)  10
Sinus tachycardia  1  3/13 (23.08%)  8
Endocrine disorders   
Hyperthyroidism  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/13 (7.69%)  2
Constipation  1  2/13 (15.38%)  2
Dry mouth  1  5/13 (38.46%)  9
Nausea  1  4/13 (30.77%)  8
Vomiting  1  2/13 (15.38%)  3
General disorders   
Chills  1  1/13 (7.69%)  1
Edema limbs  1  1/13 (7.69%)  1
Fatigue  1  7/13 (53.85%)  11
Fever  1  3/13 (23.08%)  4
Infusion related reaction  1  1/13 (7.69%)  1
Malaise  1  1/13 (7.69%)  1
Pain  1  1/13 (7.69%)  1
Infections and infestations   
Infections and infestations - Other, yeast infection  1  1/13 (7.69%)  1
Mucosal infection  1  1/13 (7.69%)  1
Investigations   
Neutrophil count decreased  1  1/13 (7.69%)  2
White blood cell decreased  1  2/13 (15.38%)  3
Metabolism and nutrition disorders   
Hypermagnesemia  1  1/13 (7.69%)  1
Hypernatremia  1  1/13 (7.69%)  1
Hypokalemia  1  1/13 (7.69%)  1
Hypophosphatemia  1  2/13 (15.38%)  3
Musculoskeletal and connective tissue disorders   
Back pain  1  1/13 (7.69%)  1
Neck pain  1  1/13 (7.69%)  1
Nervous system disorders   
Dysgeusia  1  1/13 (7.69%)  1
Headache  1  4/13 (30.77%)  7
Psychiatric disorders   
Anxiety  1  1/13 (7.69%)  1
Insomnia  1  2/13 (15.38%)  2
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/13 (7.69%)  1
Sore throat  1  2/13 (15.38%)  2
Skin and subcutaneous tissue disorders   
Dry skin  1  1/13 (7.69%)  2
Rash maculo-papular  1  2/13 (15.38%)  3
Vascular disorders   
Hypertension  1  8/13 (61.54%)  41
Hypotension  1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Norberg, DO
Organization: National Cancer Institute
Phone: 301-275-9668
EMail: scott.norberg@nih.gov
Layout table for additonal information
Responsible Party: Scott Norberg, D.O., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02859454    
Other Study ID Numbers: 160160
16-C-0160
First Submitted: August 6, 2016
First Posted: August 9, 2016
Results First Submitted: April 24, 2019
Results First Posted: May 14, 2019
Last Update Posted: November 2, 2021