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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
Sponsor:
Information provided by (Responsible Party):
Advaxis, Inc.

Study Description
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Brief Summary:
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).

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ADXS11-001 Biological: ADXS11-001


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0 [ Time Frame: 12 weeks ]
  2. Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 3 years ]

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

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

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.
Contacts and Locations
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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): NCT02164461


Locations
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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
Sponsors and Collaborators
Advaxis, Inc.
More Information
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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
Keywords provided by Advaxis, Inc.:
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
Additional relevant MeSH terms:
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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