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NCT02164461 · ClinicalTrials.gov registry record · Phase 1

Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer

A Phase 1 study, sponsored by Advaxis.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02164461: Completed Phase 1 study, sponsored by Advaxis.

NCT02164461 is a Phase 1 study that has completed, run by Advaxis. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02164461, a Phase 1 study, has completed, sponsored by Advaxis.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10\^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Interventions

  • BIOLOGICAL Axalimogene filolisbac

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2015-03-04
Est. Completion 2017-03-08
Phase Phase 1

Sponsor

Advaxis

9 total trials

What the Registry Record Tells You About NCT02164461

The ClinicalTrials.gov registry entry for NCT02164461 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advaxis, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Axalimogene filolisbac is the first listed.

NCT02164461 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02164461 about?

NCT02164461 is a clinical study titled "Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer". To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10\^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcino...

What is the current status of trial NCT02164461?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-03-04. Estimated completion is 2017-03-08.

What interventions are being tested in trial NCT02164461?

The interventions under investigation include: Axalimogene filolisbac (BIOLOGICAL).

Who is sponsoring clinical trial NCT02164461?

This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.