ADXS11-001 High Dose HPV+ Cervical Cancer
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
Conditions: official terms
Adenocarcinoma - Carcinoma - Carcinoma, Adenosquamous - Carcinoma, Small Cell - Carcinoma, Squamous Cell - Small Cell Lung Carcinoma - Uterine Cervical Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ADXS11-001
Type: Biological
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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.

- Patients with unidimensionally-measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded). Each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT) scan, magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT scan or MRI.

- Patients with at least 1 'Target Lesion' for response assessment per RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.

- Subject has 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).

- Subject may have received ≤2 prior regimens for the treatment of their metastatic disease.

- Subject has measurable and/or evaluable disease for response assessment per RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.

- Subject is able to provide written informed consent.

- Subject demonstrates adequate organ function as defined in protocol. All screening laboratory testing should be performed within 5 days of treatment initiation.

- Subject has resolved acute effects of any prior therapy to baseline severity of Grade <2 per CTCAE except for AEs not constituting a safety risk by investigator judgment.

- Subject must have an ECOG performance status of 0 or 1.

- Women of childbearing potential with a negative urine pregnancy test at Screening.

- Female subjects of childbearing potential must agree to ongoing use 2 methods of study doctor approved birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study from Screening through 120 days after the last dose of study medication (see Section 12.11). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year.

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 not recovered (ie, Grade ≤1 at baseline) from adverse events, with the exception of alopecia due to previously administered agent(s).

- 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 an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

- Has neuropathy (sensory and motor) ≥Grade 3 per CTCAE v 4.0.

- Subject has diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

- Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

- Subject has concurrent unstable or uncontrolled medical condition (eg, active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which in the opinion of the investigator, could compromise the patient or the study.

- Subject is pregnant or breastfeeding, or expecting to conceive a child/children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

- Subject is currently participating in or has participated in a study of an investigational agent(s) or using an investigational device within 4 weeks of the first dose of trial treatment.

- Subject has active infection requiring systemic therapy or is dependent on or currently receiving antibiotics that cannot be discontinued before dosing. (Note: Subjects who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any ADXS11-001 infusion).

- Subject is dependent on, currently receiving or has received within the past 4 weeks corticosteroids, with the exception of hormonal replacement therapy, topical corticosteroids and occasional inhaled corticosteroids, as indicated.

- Subject has a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial.

- Subject with any other serious or uncontrolled physical or mental condition/disease that, as judged by the investigator, could place the patient at higher risk derived from his/her participation in the study, could confound results of the study, or would be likely to prevent the patient from complying with the requirements of the study or completing the study.

- Subject has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

- Subject has a known active hepatitis B (eg, HBsAg reactive) or hepatitis C (eg, HCV RNA [qualitative] is detected).

- Subject has received a live vaccine within 30 days prior to the first dose of trial treatment.

- Subject has a known allergy to any component of the study drug formulations.

- Subject has a history of listeriosis or prior ADXS11-001 vaccine therapy.
Location
Georgia Regents University Cancer Center
Augusta, Georgia, United States
Status: Recruiting
Contact: Pam Bourbo, RN, MPH,OCN, CCRC - 888-658-0422 - pbourbo@gru.edu
Start Date
January 2015
Sponsors
Advaxis, Inc.
Source
Advaxis, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page