1)cervical cancer 2) A malignant tumor of the cervix the lowermost part of the uterus
Conditions
Interventions
ADXS11-001 (1 x 10 9) CFU or placebo IV infusion over 60 minutes.
1 dose administered every 3 weeks (Weeks 1, 4 and 7) for 3 doses (Prime Phase),
thereafter, subjects will receive 1 dose every 8 week
locally advanced cervical cancer
Sponsors
Advaxis, Inc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Subjects with: o Histological diagnosis of squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix who have undergone definitive therapy with a curative intent;• Subjects may have: o Stage IB2, IIA2, IIB with any of the following pelvic lymph node metastases criteria: - Biopsy proven pelvic node(s) - 2 or more positive nodes by MRI/CT >=1.5 cm shortest dimension - 2 or more positive pelvic nodes by PET with standard uptake value >=2.5 OR o All Stage IIIA, IIIB, IVA OR o Any FIGO stage with para-aortic lymph node metastases criteria (defined by 1 of the following): - Biopsy proven para-aortic node(s) - 1 or more positive para-aortic node(s) by MRI/CT >1.5 cm shortest dimension - 1 or more positive para-aortic node(s) by PET with SUV >2.5;Subjects must have received definitive therapy with curative intent, which consist of at least 4 weeks of treatment with cisplatin and a minimum of 40 Gy external beam radiation therapy (EBRT). NOTE: Brachytherapy is permitted.;• Subjects must be: o Age 18 years or older o GOG performance status 0 - 1 o ANC >=1000 x 109/L o Platelets >=75 x 109/L o Bilirubin
Exclusion criteria
Exclusion criteria: • Subjects who have not achieved disease-free status (e.g. no evidence of measurable disease or non-measurable disease per RECIST 1.1) after completion of CCRT administered with curative intent. • Subjects with FIGO stage IVB • Histologies other than described above (neuroendocrine cancers are excluded) • Subjects who have undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy NOTE: Women who have had a partial/subtotal hysterectomy are eligible to participate in the study. • 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. • Who are receiving, plan, or anticipate on receiving PI3K or TNF* inhibitors • Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and ampicillin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is DFS measured from the time of randomization to recurrence or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The safety objective of this study is to determine and compare the frequency and severity of AEs as assessed by NCI CTCAE v 4.03 for the regimens administered on this study. - The exploratory endpoint are patient reported outcomes | — |
Countries
Argentina, Brazil, Canada, Chile, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan (Province of China), Ukraine, United States of America
Outcome results
None listed