Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
Public ClinicalTrials.gov record NCT03493945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03493945
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 59 participants
Conditions and interventions
Conditions
Interventions
- M7824 Biological
- N-803 Drug
- MVA-BN-Brachyury Biological
- FPV-Brachyury Biological
- Epacadostat Drug
- Acetaminophen Drug
- Ibuprofen Drug
- Naproxen Drug
- Benadryl Other
- EKG Diagnostic Test
- Bone scan Diagnostic Test
- CT chest, abdomen and pelvis Diagnostic Test
- MRI Diagnostic Test
Biological · Drug · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2018
- Primary completion
- Oct 7, 2024
- Completion
- Oct 7, 2024
- Last update posted
- Sep 29, 2025
2018 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03493945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03493945 live on ClinicalTrials.gov.