Phase 3 study of ADXS11-001 administered following chemoradiation as adjuvant treatment for high risk locally advanced cervical cancer: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)
- Conditions
- 1)cervical cancer 2) A malignant tumor of the cervixthe lowermost part of the uterus1003859410013364
- Registration Number
- NL-OMON47237
- Lead Sponsor
- Advaxis, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
• 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 <=1.5 x ULN
o AST or ALT <=2.5 x ULN
o Serum creatinine or measured creatinine clearance <=1.5 xULN
o Toxicities resulting from definitive therapy must resolve to <=Grade 1 prior to randomization, with the exception of peripheral neuropathy (sensory and motor) which must resolve to <=Grade 2.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for this study is DFS measured from the time of<br /><br>randomization to recurrence or death.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The safety objective of this study is to determine and compare the frequency<br /><br>and severity of AEs as assessed by NCI CTCAE v 4.03 for the regimens<br /><br>administered on this study.<br /><br><br /><br>- The exploratory endpoint are patient reported outcomes</p><br>