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NCT03707587 · ClinicalTrials.gov registry record · Phase 2
M7824 in People With Recurrent Respiratory Papillomatosis
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03707587: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03707587 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03707587, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: Programmed cell death protein 1 (PD-L1) is a protein on the surface of cells. It regulates if a cell can be killed by immune system cells. It is thought to be able to affect the immune system response to diseased cells like those infected with a virus. The molecule M7824 interferes with the activity of PD-L1. It could help the immune system kill cells infected with a virus . Since recurrent respiratory papillomatosis is caused by a virus infection, this molecule could help. Objective: To see if M7824 works in treating recurrent respiratory papillomatosis. Eligibility: Adults ages 18 years or older with recurrent respiratory papillomatosis Design: Participants will be screened with: Medical history Physical exam Blood and pregnancy tests Endoscopy procedure in clinic. A small tube with a camera will look at the inside of the nose, throat, larynx, and upper windpipe. Some participants will also be screened with a chest scan. At the start of the study, participants will: Have a sedated endoscopy procedure where biopsies will be taken. Have blood tests. Have apheresis. Blood will be collected by a tube in an arm vein. A machine will remove white blood cells. The rest of the blood will be returned into an arm vein. Fill out a voice questionnaire. Participants will get the study molecule into a vein over about 1 hour. They will get it every other week for up to 12 weeks. Participants will repeat screening and starting procedures throughout the study. They will also review side effects and any medicine they are taking. When they are done with the study treatment, participants will be evaluated by repeating the study procedures. They may be evaluated periodically until their disease progresses.
Interventions
- DRUG M7824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2022-07-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03707587
The ClinicalTrials.gov registry entry for NCT03707587 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which M7824 is the first listed.
NCT03707587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03707587 about?
NCT03707587 is a clinical study titled "M7824 in People With Recurrent Respiratory Papillomatosis". Background: Programmed cell death protein 1 (PD-L1) is a protein on the surface of cells. It regulates if a cell can be killed by immune system cells. It is thought to be able to affect the immune system response to diseased cells like those infected with a virus. The molecule M7824 interferes with...
What is the current status of trial NCT03707587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-12-19. Estimated completion is 2022-07-06.
What interventions are being tested in trial NCT03707587?
The interventions under investigation include: M7824 (DRUG).
Who is sponsoring clinical trial NCT03707587?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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