Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer (AIM2CERV)

Phase 1

• Conditions: High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy and radiation therapy.; MedDRA version: 20.0Level: LLTClassification code 10008231Term: Cervical cancer recurrentSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008236Term: Cervical cancer stage IVSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008235Term: Cervical cancer stage IIISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008234Term: Cervical cancer stage IISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008233Term: Cervical cancer stage ISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004844-20-PL
• Lead Sponsor: Advaxis, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-08
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 450

Inclusion 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 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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 TNF inhibitors.
- Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and ampicillin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified