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Clinical Trials List

Protocol NumberADXS001-02
NCT Number(ClinicalTrials.gov Identfier)NCT02853604

2016-11-01 - 2019-07-31

Phase III

Terminated6

ICD-10D06

Carcinoma in situ of cervix uteri

A Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV

  • Trial Applicant

    Syneos Health

  • Sponsor

    Advaxis, Inc

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Cheng-Yang Chou Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 何志明 Division of Obstetrics & Gynecology
Cathay General Hospital

Co-Principal Investigator

  • 黃家彥 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

  • 陳鵬宇 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ting-Chang Chang Division of Obstetrics & Gynecology
Linkou Chang Gung Medical Foundation

Taiwan National PI

張廷彰

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Stop recruiting

Audit

None

Principal Investigator Wen-Fang Cheng Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Condition/Disease

High Risk Locally Advanced Cervical Cancer

Objectives

Primary Objective: To compare the disease free survival (DFS) of ADXS11-001 to placebo administered in the adjuvant setting following concurrent chemotherapy and radiotherapy (CCRT) administered with curative intent to subjects with high-risk locally advanced squamous, adenosquamous, or adenocarcinoma of the cervix (HRLACC). Secondary Objectives  To determine and compare the frequency and severity of adverse events (AEs) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the regimens administered on this study.  To evaluate the overall survival (OS) of ADXS11-001 administered in the adjuvant setting following definitive therapy of CCRT in subjects with HRLACC.

Test Drug

ADXS11-001

Active Ingredient

Axalimogene Filolisbac

Dosage Form

Injection

Dosage

1 x 109

Endpoints

Efficacy: DFS evaluated using progression-based evaluation methodology
every 3 months, beginning 3 months after the first dose for the first 2 years
and then every 6 months for the next 3 years for a total of 5 years; and OS
Safety: assessed at every visit by comparing treatment-related adverse
events (AEs); changes in physical examinations, vital signs measurements,
clinical laboratory evaluations, and Lm surveillance blood cultures; an
independent Data Monitoring Committee (DMC) will evaluate and analyze
accrued subject data periodically throughout the study.

Inclution 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 10
9
/L o
Platelets ≥75 x 10
9
/L o
Bilirubin ≤1.5 x ULN
o AST or ALT ≤2.5 x ULN
o Serum creatinine or measured creatinine clearance ≤1.5 x
ULN
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.

Exclusion Criteria

Key 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 TNF𝛼
inhibitors
 Has a contraindication (sensitivity or allergy) to
trimethoprim/sulfamethoxazole and ampicillin.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    450 participants

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