Clinical Trials /

ADXS11-001 High Dose HPV+ Cervical Cancer

NCT02164461

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).

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

ADXS11-001 High Dose <span class="go-doc-concept go-doc-alteration">HPV+</span> Cervical Cancer

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

    NCT ID: NCT02164461

    ORG ID: Lm-LLO-E7-1401

    Trial 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

    Trial Interventions

    Drug Synonyms Arms

    Trial 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).

    Detailed Description

    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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0

    Frequency and severity of adverse effects as assessed by CTCAE v 4.0

    Secondary Outcome Measures

    Changes in clinical immunology based upon serum

    Proportion of patients who have objective tumor response (complete or partial)

    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