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A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal

NCT02399813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-20

Study results available
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Summary

This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.

Conditions

Interventions

DRUG

Axalimogene filolisbac

Sponsors & Collaborators

  • Advaxis, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-02
Primary Completion
2019-01-03
Completion
2019-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02399813 on ClinicalTrials.gov