Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
Condition: High Risk Cervical Cancer; Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: ADXS11-001; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent
      chemotherapy and radiation therapy. This is a group of participants with a significant unmet
      need. The estimated probability of disease recurrence or death within 4 years of diagnosis is
      50% and the prognosis is very grave for those who experience a recurrence.

      The purpose of the study was to compare the disease free survival (DFS) of ADXS11-001 to
      placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT)
      with curative intent in participants with HRLACC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma,
             or adenosquamous carcinoma of the cervix. Histologic confirmation of the original
             primary tumor is required.

          -  Participants with HRLACC.

          -  Participants included those with stage IB2, IIA2, IIB with pelvic lymph node
             metastases; all FIGO Stage IIIA, IIIB, IVA or any FIGO Stage (except stage IVB) with
             para-aortic lymph node metastases as defined by the FIGO 2014 staging criteria for
             carcinoma of the cervix uteri.

          -  Participants must have received definitive therapy with curative intent, which consist
             of at least 4 weeks of treatment with cisplatin and a minimum of 40Gy external beam
             radiation therapy (EBRT).

          -  Have performance status of 0 or 1 on the gynaecologic Oncology Group (GOG) performance
             scale

          -  Demonstrate adequate organ function

        Exclusion Criteria:

          -  Has not achieved disease-free status after completion of CCRT administered with
             curative intent.

          -  Has International Federation of Gynecology and Obstetrics (FIGO) Stage IVB

          -  Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma
             of the cervix.

          -  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)).

          -  Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and
             ampicillin.

          -  Has 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