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NCT02853604 · ClinicalTrials.gov registry record · Phase 3
Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
A Phase 3 study, sponsored by Advaxis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
NCT02853604: Clinical Trial Phase 3 study, sponsored by Advaxis.
NCT02853604 is a Phase 3 study that was terminated before completion, run by Advaxis. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02853604, a Phase 3 study, was terminated before completion, sponsored by Advaxis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
Study Summary
Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence. The purpose of the study was to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT) with curative intent in participants with HRLACC.
Primary Outcome
DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine r
Interventions
- DRUG Placebo
- DRUG ADXS11-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 3 |
Why NCT02853604 stopped before completion
NCT02853604 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02853604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02853604 about?
NCT02853604 is a clinical study titled "Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer". Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosi...
What is the current status of trial NCT02853604?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2015-12-15. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT02853604?
The interventions under investigation include: Placebo (DRUG), ADXS11-001 (DRUG).
Who is sponsoring clinical trial NCT02853604?
This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02853604's enrollment target sits among peer trials
110 1657th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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