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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02399813
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
Advaxis, Inc.

Brief 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 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

Condition or disease Intervention/treatment Phase
Anal Cancer Rectal Cancer Drug: ADXS11-001 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal
Actual Study Start Date : September 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ADXS11-001 Drug: ADXS11-001

Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 2 years ]
  2. Overall response rate for all subjects [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399813

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United States, California
Duarte, California, United States
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New York
Buffalo, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Pennsylvania
Fox Chase
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Advaxis, Inc.
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Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT02399813    
Other Study ID Numbers: ADXS001-06
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Anus Diseases