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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). 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.
Primary Outcome
RFS is defined as the time from the start of intravesical Bacillus Calmette-Guerin (TICE BCG) therapy (week 3) until disease recurrence or death due to any cause in each arm. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.
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 |
What the finished NCT02015104 record still lists
NCT02015104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02015104's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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