CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Axalimogene filolisbacbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02164461
NCT02164461Phase 1Completed

A Phase 1 Study Evaluating High Dose ADXS11-001 Treatment in Women With Carcinoma of the Cervix (ADXS001-07)

Advaxis, Inc.·interventional·Posted Jun 16, 2014·Updated May 20, 2024

In Brief

A Phase 1 clinical trial evaluating Axalimogene filolisbac for Effects of Immunotherapy and 8 related conditions. Completed, enrolled 12 participants across 2 sites.

Detailed 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).

Study Details

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 16, 2014
Enrollment StartMar 4, 2015
Primary CompletionMar 8, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.0 years ago

Interventions

Axalimogene filolisbacbiological