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NCT03315871 · ClinicalTrials.gov registry record · Phase 2
Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03315871: Completed Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT03315871 is a Phase 2 study of Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315871, a Phase 2 study of Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people. Objective: To see if the combination treatment of PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact in people with biochemically recurrent prostate cancer. Eligibility: People ages 18 and older with certain kinds of prostate cancer Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * A scan of the neck, chest, abdomen, and pelvis * A bone scan A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status. Some participants will have close monitoring with four monthly PSA checks. All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after. Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans. Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
Primary Outcome
Percentage of participants with a toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Conditions Studied
Interventions
- BIOLOGICAL Antigen direct immunotherapy: PROSTVAC-V
- BIOLOGICAL Antigen direct immunotherapy: PROSTVAC-F
- DRUG MSB0011359C (M7824)
- BIOLOGICAL Antigen direct immunotherapy: CV301
- DIAGNOSTIC_TEST CT scan of chest
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 2 |
What the finished NCT03315871 record still lists
NCT03315871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Antigen direct immunotherapy: PROSTVAC-V is the first listed.
NCT03315871 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03315871 about?
NCT03315871 is a clinical study titled "Combination Immunotherapy in Biochemically Recurrent Prostate Cancer". Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor ...
What is the current status of trial NCT03315871?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-03-20. Estimated completion is 2024-06-04.
What conditions does trial NCT03315871 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03315871?
The interventions under investigation include: Antigen direct immunotherapy: PROSTVAC-V (BIOLOGICAL), Antigen direct immunotherapy: PROSTVAC-F (BIOLOGICAL), MSB0011359C (M7824) (DRUG), Antigen direct immunotherapy: CV301 (BIOLOGICAL), CT scan of chest (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03315871?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315871 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03315871's enrollment target sits among peer trials
40 526th of 735 higher than 201 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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