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NCT03789097 · ClinicalTrials.gov registry record · Phase 1
Vaccination With Flt3L, Radiation, and Poly-ICLC
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03789097: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03789097 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03789097, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a combination of 4 therapies, three of which are used to treat a single "target site" of your cancer (such as a lymph node or a single tumor), and the 4th is given directly into the blood stream (intravenous or "IV"). 1. Radiation: The target site --lymph node or tumor (the one what will be injected) --will get two small treatments of radiation. Radiation is often times used to shrink and kill tumors in patients with certain types of lymphoma, breast cancer and head and neck cancer, however, the dose of radiation that you will receive --one dose on day one of the clinical trial and one dose on day two --is 10 to 20 time less radiation that you would receive for treatment of these cancers. 2. Flt3L/CDX-301 is an immune cell growth factor, similar to white blood cell growth factors (Neupogen or Neulasta) or red blood cell growth factors (EPO or Epogen) that you may have received to help protect your blood cells previously. Flt3L causes your body to make more immune cells, specifically a type of immune cell called "dendritic cells". 3. Poly-ICLC is an immune cell activating factor. Its function is to turn on the immune cells that have been brought to the tumor by Flt3L. 4. Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to kill your tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with many different types of cancer including head and neck cancer. Pembrolizumab is not FDA approved to treat patients with non-Hodgkin's lymphoma or metastatic breast cancer, as it has not been effective at treating these cancers when used alone. While most people do not have immediate side effects when this medication is given, it has the ability to cause side effects for.
Primary Outcome
DLTs recorded and graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03, within DLT evaluation window of 63 days (end of cycle 1 of pembrolizumab) from initiation of in situ vaccine.
Interventions
- DRUG Pembrolizumab
- RADIATION Radiation
- DRUG Poly ICLC
- DRUG Flt3L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2025-09-22 |
| Phase | Phase 1 |
What the finished NCT03789097 record still lists
NCT03789097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03789097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03789097 about?
NCT03789097 is a clinical study titled "Vaccination With Flt3L, Radiation, and Poly-ICLC". This is a combination of 4 therapies, three of which are used to treat a single "target site" of your cancer (such as a lymph node or a single tumor), and the 4th is given directly into the blood stream (intravenous or "IV"). 1. Radiation: The target site --lymph node or tumor (the one what will be...
What is the current status of trial NCT03789097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-04-05. Estimated completion is 2025-09-22.
What interventions are being tested in trial NCT03789097?
The interventions under investigation include: Pembrolizumab (DRUG), Radiation (RADIATION), Poly ICLC (DRUG), Flt3L (DRUG).
Who is sponsoring clinical trial NCT03789097?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03789097's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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