ADXS11-001 High Dose HPV+ Cervical Cancer

Study Overview
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Brief Summary
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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).

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

Conditions
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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 / Treatment
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* Biological: ADXS11-001


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADXS11-001<br> | Biological: ADXS11-001<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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