Clinical Trials /

ADXS11-001 High Dose HPV+ Cervical Cancer

NCT02164461

Description:

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).

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: ADXS11-001 High Dose HPV+ Cervical Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: Lm-LLO-E7-1401
  • NCT ID: NCT02164461

Conditions

  • 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

Interventions

DrugSynonymsArms
ADXS11-001ADXS11-001

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ADXS11-001Experimental
  • ADXS11-001

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Time Frame:12 weeks
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Advaxis, Inc.

Trial Keywords

  • 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

Last Updated

March 5, 2019