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Trial record 3 of 10 for:    adxs11-001

ADXS11-001 High Dose HPV+ Cervical Cancer

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: NCT02164461
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Advaxis, Inc.

Tracking Information
First Submitted Date  ICMJE June 13, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • 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 ]
  • Proportion of patients who survive for at least 12 months [ Time Frame: 12 months ]
  • Distribution of progression-free survival [ Time Frame: Up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • 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 ]
  • Distribution of overall survival [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADXS11-001 High Dose HPV+ Cervical Cancer
Official Title  ICMJE PHASE 1-2 STUDY EVALUATING HIGH DOSE ADXS11-001 (1 x 10^10 CFU) TREATMENT IN WOMEN WITH HPV+ CARCINOMA OF THE CERVIX
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Biological: ADXS11-001
Study Arms  ICMJE Experimental: ADXS11-001
Intervention: Biological: ADXS11-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 27, 2015)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2014)
43
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02164461
Other Study ID Numbers  ICMJE Lm-LLO-E7-1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Advaxis, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Advaxis, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Advaxis, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP