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).
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
Drug | Synonyms | Arms |
---|
ADXS11-001 | | ADXS11-001 |
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
Name | Type | Description | Interventions |
---|
ADXS11-001 | Experimental | | |
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