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NCT03493945 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT03493945: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03493945 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03493945, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
Background: Immunotherapy drugs help the body to fight cancer. Scientists think that combining some of these drugs will make them work better than when used alone. This may be true for many types of cancer, including castration-resistant prostate cancer (CRPC). Objective: To test if any of the combinations of drugs below have anti-prostate cancer activity and to test if they are safe. 1. Bavarian-Nordic (BN)-brachyury, bintrafusp alfa (M7824). 2. Bavarian-Nordic (BN)-brachyury, bintrafusp alfa (M7824) + Anktiva (N-803). 3. Bavarian-Nordic (BN)-brachyury, bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat. Eligibility: People ages 18 and older with CRPC or another metastatic cancer Design: Participants will be screened with: * Medical history * Physical exam * Computed tomography (CT) or magnetic resonance imaging (MRI) scans * Possible bone imaging * Blood, urine, and heart tests * Possible tumor biopsy Participants will be treated with a 2-, 3- or 4-drug combinations of the following study drugs in 2-week cycles: * Participants will receive M7824 by intravenous (IV) once every 2 weeks. * Participants will receive N-803 by injection once every 2 weeks. They will record any skin changes at the injection site in a diary. * Participants will receive BN-brachyury as 4 injections to different limbs. They will get the first 3 doses 2 weeks apart. Then they will get doses every 4 weeks for 6 months, then every 3 months for 2 years, then every 6 months. * Participants will take Epacadostat orally every 12 hours. They will keep a pill diary. Participants will have physical exams and blood and urine tests at the start of each cycle. They may have scans every 12 weeks. Participants will continue treatment until their disease gets worse or they cannot tolerate the side effects. Participants will have a follow-up visit 4-5 weeks after they stop treatment. They will have a physical exam and blood tests. They may be asked to return for scans every 3 months.
Interventions
- DRUG Epacadostat
- DRUG N-803
- BIOLOGICAL M7824
- BIOLOGICAL MVA-BN-Brachyury
- BIOLOGICAL FPV-Brachyury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2024-10-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03493945
The ClinicalTrials.gov registry entry for NCT03493945 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 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 5 interventions - of which Epacadostat is the first listed.
NCT03493945 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03493945 about?
NCT03493945 is a clinical study titled "Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)". Background: Immunotherapy drugs help the body to fight cancer. Scientists think that combining some of these drugs will make them work better than when used alone. This may be true for many types of cancer, including castration-resistant prostate cancer (CRPC). Objective: To test if any of the co...
What is the current status of trial NCT03493945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2018-05-01. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT03493945?
The interventions under investigation include: Epacadostat (DRUG), N-803 (DRUG), M7824 (BIOLOGICAL), MVA-BN-Brachyury (BIOLOGICAL), FPV-Brachyury (BIOLOGICAL).
Who is sponsoring clinical trial NCT03493945?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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