Clinical Trials

Title   ADXS001-02 AIM2CERV
Principal Investigator/ Physician   Jennifer Scalici, MD
Protocol┬áNo.   ADXS11-001
Open Date   01/10/2017
Gender   Female
Cancer Site   Cervical
Status   Open
Sponsor   Advaxis
Contact Email   MCI Clinical Trials

Protocol Tiltle: A phase 3 trial of ADXS11-001 administered following chemo-radiation as adjuvant treatment for high risk locally advanced cervical cancer

Inclusion Criteria: Patient must have biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix; FIGO stage IB2, IIB with biopsy proven pelvic node metastases, 2 or more pelvic nodes by CT or MRI measuring ≥ 1.5 cm in shortest dimension, 2 or more pelvic nodes by PET with SUV ≥ 2.5 cm or all FIGO stage IIIA, IIIB, IVA or any FIGO stage with para-aortic lymph node metastases criteria; must have received CCRT with curative intent according to either institutional or national guidelines with a minimum of at least 4 weeks exposure with cisplatin and a minimum of 40 Gy external beam radiation therapy (EBRT); completion of CCRT, including brachytherapy, defined as the last dose of radionat or chemotherapy, must be completed by no more than 10 weeks prior to the initiation of the screening period; GOG performance scale of 0 or 1

Exclusion Criteria: patient has not achieved disease-free status after completion of CCRT administered with curative intent; has FIGO stage IVB; has histologies other than squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix; had any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for other invasive malignancies within 2 years (concurrent use of hormones for non-cancer-related conditions is acceptable); has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed; currently receiving or have a known plan to receive in the future a PI3K or TNF inhibitors; has received a live vaccine within 30 days prior to the first dose of study treatment; history of other invasive malignancies within 3 years of randomization; has bilateral hyronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria; has known active CNS metastases and/or carcinomatous meningitis; has liver cirrhosis or any other impaired hepatic function as dtermined by serum enzymes; has undergone a previous hysterectomy.

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