Clinical trial NCT02853604: Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
Official title: Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: High Risk Cervical Cancer
Advanced Cervical Cancer
Lead sponsor: Advaxis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
First posted: 2016-08-03
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From first dose of study drug until end of study (Up to 44.7 months)
measure: Overall Survival (OS)
timeFrame: From the date of randomization until death due to any cause (Maximum duration: 44.7 months)
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
facility: Site
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Duarte
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
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city: Orange
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state: California
city: San Francisco
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city: Tallahassee
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city: Tampa
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state: Georgia
city: Maywood
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state: Illinois
city: Park Ridge
country: United States
facility: Site
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city: Indianapolis
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city: Indianapolis
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city: Baltimore
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city: Las Vegas
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city: Hackensack
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city: Newark
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city: Albany
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city: Brooklyn
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city: Charlotte
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state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
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facility: Site
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city: Hilliard
country: United States
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state: Ohio
city: Kettering
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state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
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state: Tennessee
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facility: Site
state: Texas
city: Galveston
country: United States
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state: Texas
city: Houston
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city: Milwaukee
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state: Wisconsin
city: La Rioja
country: Argentina
facility: Site
city: Rio De Janeiro
country: Brazil
facility: Site
state: RJ
city: Natal
country: Brazil
facility: Site
state: RN
city: Calgary
country: Canada
facility: SITE
state: Alberta
city: Montréal
country: Canada
facility: SITE
state: Quebec
city: Sherbrooke
country: Canada
facility: Site
state: Quebec
city: Temuco
country: Chile
facility: SITE
state: Araucania
city: Santiago de Chile
country: Chile
facility: SITE
state: Region Metropolitana
city: Seongnam
country: Korea, Republic of
facility: Site
city: Seoul
country: Korea, Republic of
facility: Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Yangsan
country: Korea, Republic of
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city: Kota Bharu
country: Malaysia
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state: Kelantan
city: Kota Bharu
country: Malaysia
facility: Site
state: Kelantan
city: Ampang
country: Malaysia
facility: Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
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city: Pulau Pinang
country: Malaysia
facility: Site
city: Mexico City
country: Mexico
facility: Site
state: D.f.
city: Chihuahua
country: Mexico
facility: Site
city: Białystok
country: Poland
facility: Site
city: Lublin
country: Poland
facility: Site
city: Krasnodar
country: Russian Federation
facility: Site
state: Krasnodar Region
city: Arkhangel'sk
country: Russian Federation
facility: Site
city: Moscow
country: Russian Federation
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city: Nal'chik
country: Russian Federation
facility: Site
city: Nizhny Novgorod
country: Russian Federation
facility: Site
city: Obninsk
country: Russian Federation
facility: Site
city: Orenburg
country: Russian Federation
facility: Site
city: Pyatigorsk
country: Russian Federation
facility: Site
city: Rostov-on-Don
country: Russian Federation
facility: Site
city: Saint Petersburg
country: Russian Federation
facility: Site
city: Saint Petersburg
country: Russian Federation
facility: Site
city: Sochi
country: Russian Federation
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city: Ufa
country: Russian Federation
facility: Site
city: Volgograd
country: Russian Federation
facility: Site
city: Belgrade
country: Serbia
facility: Site
city: Belgrade
country: Serbia
facility: Site
city: Kragujevac
country: Serbia
facility: Site
city: Sremska Kamenica
country: Serbia
facility: Site
city: Barcelona
country: Spain
facility: Site
city: Barcelona
country: Spain
facility: Site
city: Barcelona
country: Spain
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city: Córdoba
country: Spain
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city: El Palmar
country: Spain
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city: Elche
country: Spain
facility: Site
city: Girona
country: Spain
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city: Madrid
country: Spain
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city: Madrid
country: Spain
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city: Málaga
country: Spain
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city: Palma De Mallorca
country: Spain
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city: Palma De Mallorca
country: Spain
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city: Sabadell
country: Spain
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city: Seville
country: Spain
facility: Site
city: Valencia
country: Spain
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city: Valencia
country: Spain
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city: Zaragoza
country: Spain
facility: Site
city: Taichung
country: Taiwan
facility: Site
city: Tainan
country: Taiwan
facility: Site
city: Taipei
country: Taiwan
facility: Site
city: Taipei
country: Taiwan
facility: Site
city: Taipei
country: Taiwan
facility: Site
city: Taoyuan
country: Taiwan
facility: Site
city: Chernivtsi
country: Ukraine
facility: Site
city: Dnepropetrovsk
country: Ukraine
facility: Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Site
city: Kharkiv
country: Ukraine
facility: Site
city: Khmelnytskyi
country: Ukraine
facility: Site
city: Luts'k
country: Ukraine
facility: Site
city: Poltava
country: Ukraine
facility: Site
city: Ternopil'
country: Ukraine
facility: Site
city: Vinnytsia
country: Ukraine
facility: Site
city: Zaporizhzhya
country: Ukraine
facility: Site
Study officials:
References: