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NCT02166905 · ClinicalTrials.gov registry record · Phase 1
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02166905 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 40 participants.
The verdict
NCT02166905, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who no longer have evidence of disease. Antigens (such as cancer/testis antigen \[NY-ESO-1\] protein) are found on many cancer cells. Vaccines made from NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By finding them, the immune system may then work to control or eliminate the remaining cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Epacadostat
- DRUG Poly ICLC
- OTHER Pharmacological Study
- BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10-10 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02166905
The ClinicalTrials.gov registry entry for NCT02166905 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02166905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02166905 about?
NCT02166905 is a clinical study titled "DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission". This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who...
What is the current status of trial NCT02166905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-10-10. Estimated completion is 2020-08-20.
What interventions are being tested in trial NCT02166905?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Epacadostat (DRUG), Poly ICLC (DRUG), Pharmacological Study (OTHER), DEC-205/NY-ESO-1 Fusion Protein CDX-1401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02166905?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
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