Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal

Status:	Active, not recruiting
Conditions:	Colorectal Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/7/2019
Start Date:	September 2015
End Date:	May 2019

PHASE 2 STUDY OF ADXS11-001 IN SUBJECTS WITH PERSISTENT/RECURRENT, LOCO-REGIONAL OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE ANORECTAL CANAL

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 subjects, respectively with persistent/recurrent, loco-regional or
metastatic SCCA of the anorectal canal that have received at least 1 regimen for the
treatment of advanced disease

Inclusion Criteria:

- Must have cancer of the anal canal OR rectal cancer.

- Must have metastatic disease or persistent/recurrent loco-regional disease

- Prior Therapy: may have received <2 regimens for disease in the metastatic setting. At
least one line of therapy.

- Be willing and able to provide written informed consent for the trial.

- Be ≥18 years of age on day of signing informed consent.

- Have measurable disease based on RECIST 1.1

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Demonstrate adequate organ function as defined in protocol.

- Females cannot be pregnant or breastfeeding and must take two methods of birth control

We found this trial at

sites

Indiana University

425 University Blvd.
Indianapolis, Indiana 46202

(317) 274-4591