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NCT02015104 · ClinicalTrials.gov registry record · Phase 2
Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT02015104: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02015104 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02015104, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: \- Many cancers produce two particular proteins. The immune system can target these to attack the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on people with high grade non-muscle invasive bladder cancer. They will give it to people who have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several weeks. They want to see if PANVAC plus BCG is better than BCG alone. Objective: \- To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone. Eligibility: \- Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least 1 course of BCG. Design: * Participants will be screened with blood and urine tests and abdominal scans. * Participants will be randomly assigned to get BCG only or BCG plus PANVAC. * They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer care. * They will have blood and urine tests. * All participants will get BCG in 6 weekly injections. * One group will also get PANVAC in 5 injections over 15 weeks. * Between weeks 17 and 20, participants will undergo tests of the tumor area as part of their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy. Results will be used to evaluate the different treatments. * Participants will have quarterly follow-up visits for up to 2 years.
Interventions
- BIOLOGICAL BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG))
- BIOLOGICAL PANVAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-12-18 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015104
The ClinicalTrials.gov registry entry for NCT02015104 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 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 2 interventions - of which BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)) is the first listed.
NCT02015104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02015104 about?
NCT02015104 is a clinical study titled "Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG". Background: \- Many cancers produce two particular proteins. The immune system can target these to attack the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on people wi...
What is the current status of trial NCT02015104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2013-12-18. Estimated completion is 2019-05-02.
What interventions are being tested in trial NCT02015104?
The interventions under investigation include: BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)) (BIOLOGICAL), PANVAC (BIOLOGICAL).
Who is sponsoring clinical trial NCT02015104?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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