ADXS11-001 High Dose HPV+ Cervical Cancer

March 4, 2019 updated by: Advaxis, Inc.

PHASE 1-2 STUDY EVALUATING HIGH DOSE ADXS11-001 (1 x 10^10 CFU) TREATMENT IN WOMEN WITH HPV+ CARCINOMA OF THE CERVIX

To evaluate the tolerability and safety of ADXS11-001 (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, time to progression) by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Recruiting
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
    • New York
      • Bronx, New York, United States
        • Recruiting
    • Virginia
      • Charlottesville, Virginia, United States
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy).
  • Patients who have received no more than 1 prior cytotoxic treatment regimen.
  • Subject may have received ≤2 prior regimens for the treatment of their metastatic disease.
  • Subject is able to provide written informed consent.
  • Subject must have an ECOG performance status of 0 or 1.

Exclusion Criteria:

  • In the opinion of the investigator, subject has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy.
  • Subject has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within ≤2 weeks of first ADXS11-001 infusion.
  • Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
  • Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADXS11-001
Biological: ADXS11-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Time Frame: 12 weeks
12 weeks
Frequency and severity of adverse effects as assessed by CTCAE v 4.0
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in clinical immunology based upon serum
Time Frame: Baseline to up to 24 hours after dose 3
Baseline to up to 24 hours after dose 3
Proportion of patients who have objective tumor response (complete or partial)
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advaxis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lm-LLO-E7-1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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