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NCT02632344 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients
A Phase 2 study of Recurrent Respiratory Papillomatosis, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT02632344: Active Phase 2 study of Recurrent Respiratory Papillomatosis, sponsored by Massachusetts General Hospital.
NCT02632344 is a Phase 2 study of Recurrent Respiratory Papillomatosis that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 21 participants, below the 35-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02632344, a Phase 2 study of Recurrent Respiratory Papillomatosis, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is evaluating an immune modulatory agent as a possible treatment for patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the treating agent.
Primary Outcome
A Simon two-stage design was used to assess best objective response rate based on endoscopic lesional burden and Response Evaluation Criteria in Solid Tumors (RECIST). For the endoscopic lesions burden score,T=the range of the score is 0 to 83. A lower score means decreased disease burden.
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (2)
Illinois
- NorthShore University HealthSystem - Evanston
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-04 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT02632344 still lists
NCT02632344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 35-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Recurrent Respiratory Papillomatosis appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT02632344 reports a single indexed study location in Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02632344 about?
NCT02632344 is a clinical study titled "Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients". This research study is evaluating an immune modulatory agent as a possible treatment for patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the treating agent.
What is the current status of trial NCT02632344?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2016-04. Estimated completion is 2025-12.
What conditions does trial NCT02632344 study?
This clinical trial studies the following conditions: Recurrent Respiratory Papillomatosis.
What interventions are being tested in trial NCT02632344?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT02632344?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02632344 being conducted?
This trial has 2 study locations across Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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