ADXS11-001 High Dose HPV+ Cervical Cancer
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ClinicalTrials.gov Identifier: NCT02164461 |
Recruitment Status :
Completed
First Posted : June 16, 2014
Last Update Posted : March 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Effects of Immunotherapy Metastatic/Recurrent Cervical Cancer Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Cervical Small Cell Carcinoma Stage III Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer | Biological: ADXS11-001 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PHASE 1-2 STUDY EVALUATING HIGH DOSE ADXS11-001 (1 x 10^10 CFU) TREATMENT IN WOMEN WITH HPV+ CARCINOMA OF THE CERVIX |
Actual Study Start Date : | January 2015 |
Actual Primary Completion Date : | April 2017 |
Actual Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: ADXS11-001 |
Biological: ADXS11-001 |
- Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0 [ Time Frame: 12 weeks ]
- Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 3 years ]
- Changes in clinical immunology based upon serum [ Time Frame: 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 ]

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

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): NCT02164461
United States, Florida | |
Recruiting | |
Miami, Florida, United States | |
United States, Georgia | |
Recruiting | |
Augusta, Georgia, United States, 30912 | |
United States, New York | |
Recruiting | |
Bronx, New York, United States | |
United States, Virginia | |
Recruiting | |
Charlottesville, Virginia, United States |
Responsible Party: | Advaxis, Inc. |
ClinicalTrials.gov Identifier: | NCT02164461 |
Other Study ID Numbers: |
Lm-LLO-E7-1401 |
First Posted: | June 16, 2014 Key Record Dates |
Last Update Posted: | March 5, 2019 |
Last Verified: | March 2019 |
Adenocarcinoma Carcinoma Carcinoma, Squamous Cell Uterine Cervical Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Carcinoma Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Small Cell Small Cell Lung Carcinoma Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms, Complex and Mixed |