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NCT03206047 · ClinicalTrials.gov registry record · Phase 1
Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03206047: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03206047 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03206047, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome
Will be listed individually per patient according to Common Terminology Criteria for Adverse Events version 5.0, and the number of patients experiencing each AE will be summarized using descriptive statistics.
Interventions
- DRUG Atezolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Poly ICLC
- DRUG Guadecitabine
- BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 1 |
What the finished NCT03206047 record still lists
NCT03206047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03206047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03206047 about?
NCT03206047 is a clinical study titled "Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monocl...
What is the current status of trial NCT03206047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-11-08. Estimated completion is 2020-11-10.
What interventions are being tested in trial NCT03206047?
The interventions under investigation include: Atezolizumab (DRUG), Laboratory Biomarker Analysis (OTHER), Poly ICLC (DRUG), Guadecitabine (DRUG), DEC-205/NY-ESO-1 Fusion Protein CDX-1401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03206047?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03206047's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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