Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer

Advanced Cervical Cancer Clinical Trial

— AIM2CERV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02853604
• Other study ID #: ADXS001-02
• Secondary ID: 2015-004844-20
• Status: Terminated
• Phase: Phase 3
• Start date: December 15, 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2023
• Source: Advaxis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was a double-blind, placebo-controlled randomized study of ADXS11-001 administered in the adjuvant setting after completion of CCRT in participants with HRLACC, or death. All eligible participants had received CCRT administered with curative intent according to institutional/national guidelines as well as meeting the minimum standards defined in the protocol. Participants initiated the Screening period within 10 weeks after the completion of CCRT. Baseline radiographic assessments and clinical laboratory assessments were completed no longer than 28 days prior to and 3 days prior to the first study treatment infusion, respectively. Eligible participants were randomized 1:2 to receive either placebo or ADXS11-001. Participants received 1 infusion of study treatment administered every 3 weeks for 3 doses for the first 3 months. Thereafter, participants received study treatment every 8 weeks for a total of 5 doses or until disease recurrence. Participants received a 7-day course of an oral antibiotic or placebo starting 72 hours following the completion of study treatment administration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cervical Cancer
• High Risk Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• ADXS11-001

• Placebo

Locations

Country	Name	City	State
Argentina	Site	La Rioja
Brazil	Site	Natal	RN
Brazil	Site	Rio De Janeiro	RJ
Canada	SITE	Calgary	Alberta
Canada	SITE	Montréal	Quebec
Canada	Site	Sherbrooke	Quebec
Chile	SITE	Santiago de Chile	Region Metropolitana
Chile	SITE	Temuco	Araucania
Korea, Republic of	Site	Seongnam
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Yangsan
Malaysia	Site	Ampang	Selangor
Malaysia	Site	Kota Bharu	Kelantan
Malaysia	Site	Kota Bharu	Kelantan
Malaysia	Site	Kuala Lumpur
Malaysia	Site	Pulau Pinang
Mexico	Site	Chihuahua
Mexico	Site	Mexico City	D.f.
Poland	Site	Bialystok
Poland	Site	Lublin
Russian Federation	Site	Arkhangel'sk
Russian Federation	Site	Krasnodar	Krasnodar Region
Russian Federation	Site	Moscow
Russian Federation	Site	Nal'chik
Russian Federation	Site	Nizhny Novgorod
Russian Federation	Site	Obninsk
Russian Federation	Site	Orenburg
Russian Federation	Site	Pyatigorsk
Russian Federation	Site	Rostov-on-Don
Russian Federation	Site	Saint Petersburg
Russian Federation	Site	Saint Petersburg
Russian Federation	Site	Sochi
Russian Federation	Site	Ufa
Russian Federation	Site	Volgograd
Serbia	Site	Belgrade
Serbia	Site	Belgrade
Serbia	Site	Kragujevac
Serbia	Site	Sremska Kamenica
Spain	Site	Barcelona
Spain	Site	Barcelona
Spain	Site	Barcelona
Spain	Site	Córdoba
Spain	Site	El Palmar
Spain	Site	Elche
Spain	Site	Girona
Spain	Site	Madrid
Spain	Site	Madrid
Spain	Site	Málaga
Spain	Site	Palma De Mallorca
Spain	Site	Palma De Mallorca
Spain	Site	Sabadell
Spain	Site	Seville
Spain	Site	Valencia
Spain	Site	Valencia
Spain	Site	Zaragoza
Taiwan	Site	Taichung
Taiwan	Site	Tainan
Taiwan	Site	Taipei
Taiwan	Site	Taipei
Taiwan	Site	Taipei
Taiwan	Site	Taoyuan
Ukraine	Site	Chernivtsi
Ukraine	Site	Dnepropetrovsk
Ukraine	Site	Ivano-Frankivs'k
Ukraine	Site	Kharkiv
Ukraine	Site	Khmelnytskyi
Ukraine	Site	Luts'k
Ukraine	Site	Poltava
Ukraine	Site	Ternopil'
Ukraine	Site	Vinnytsia
Ukraine	Site	Zaporizhzhya
United States	Site	Baltimore	Maryland
United States	Site	Brooklyn	New York
United States	Site	Cincinnati	Ohio
United States	Site	Dallas	Texas
United States	Site	Galveston	Texas
United States	Site	Hackensack	New Jersey
United States	Site	Hilliard	Ohio
United States	Site	Indianapolis	Indiana
United States	Site	Las Vegas	Nevada
United States	Site	Miami	Florida
United States	Site	Newark	New Jersey
United States	Site	Omaha	Nebraska
United States	Site	Orange	California
United States	Site	Park Ridge	Illinois
United States	Site	Phoenix	Arizona
United States	Site	San Francisco	California
United States	Site	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Advaxis, Inc.	Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Russian Federation,  Serbia,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine recurrence.	From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
Secondary	Number of Participants With Treatment Emergent Adverse Events	Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment & which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable & unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of study treatment. AE with onset dates on or after the first dose of study treatment were considered treatment emergent.	From first dose of study drug until end of study (Up to 44.7 months)
Secondary	Overall Survival (OS)	Overall survival was defined as the time from the date of randomization until death due to any cause.	From the date of randomization until death due to any cause (Maximum duration: 44.7 months)