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PD-1 Inhibitor
Pembrolizumab for Respiratory Papillomatosis
Phase 2
Waitlist Available
Led By Sara Pai, MD PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from study registration
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if an immunotherapy drug can treat patients with recurrent respiratory papillomatosis, a disease that causes growths in the respiratory system.
Who is the study for?
This trial is for individuals aged 12 and older with Recurrent Respiratory Papillomatosis (RRP) affecting the larynx, trachea, or lungs. Participants must have had at least three surgeries in a year to remove laryngeal lesions and show adequate organ function. Women of childbearing age must use birth control, and men must agree to contraception during the study.
What is being tested?
The trial is testing Pembrolizumab as a potential treatment for RRP. This immune modulatory agent aims to help those with significant disease in their airways by possibly reducing the growth of papillomas caused by HPV.
What are the potential side effects?
Potential side effects of Pembrolizumab include reactions related to the immune system such as inflammation in various organs, fatigue, skin rashes, digestive issues like diarrhea or constipation, liver enzyme changes, and an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years from study registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from study registration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events Through CTCAE
Overall Response Rate Via Endoscopic Lesional Burden Score and/or RECIST
Secondary study objectives
Assess Duration of Response
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Treatment will be administered on Day 1 of each cycle after all procedures/assessments have been completed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,019 Previous Clinical Trials
13,313,374 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,021 Previous Clinical Trials
5,186,860 Total Patients Enrolled
Sara Pai, MD PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to pembrolizumab or any of the ingredients in it.I have mild to moderate nerve damage but can still join the study.I have recovered from any major surgery or significant injury for at least 28 days.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.My blood counts are within normal ranges.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I haven't been diagnosed with invasive squamous cell carcinoma in the last 2 years.I have not needed systemic treatment for an autoimmune disease in the last 2 years.I have an active tuberculosis infection.I have a history of or currently have non-infectious lung inflammation.I am currently being treated for an infection.I agree to use birth control or abstain from sex during and up to 120 days after the study.I have been diagnosed with HIV.I can provide a recent biopsy or an older one with approval.I am fully active or restricted in physically strenuous activity but can do light work.My recent tests show my organs are functioning well.My blood clotting time is normal or near normal, even if I'm on blood thinners.I am at least 12 years old.I haven't had cancer treatment in the last 2 weeks or still have side effects.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My lesions are confirmed to be HPV-related by specific tests.I agree to use birth control during and for 4 months after the study.I have not received a live vaccine within the last 30 days.I have RRP with growths in my airways and needed 3+ surgeries last year.My blood clotting function is normal.My blood clotting time is normal or near normal, or controlled if I'm on blood thinners.My kidney function, measured by creatinine or GFR, is within the normal range.My cancer, from RRP, can't be treated with surgery, radiation, or chemo.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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