- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853604
Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer (AIM2CERV)
Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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La Rioja, Argentina, F5300 COE
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RJ
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Rio De Janeiro, RJ, Brazil, 20220-410
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RN
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Natal, RN, Brazil, 59075-740
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Alberta
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Calgary, Alberta, Canada, T2N4N2
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Quebec
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Montréal, Quebec, Canada, H2X0A9
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Sherbrooke, Quebec, Canada, J1H5N4
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Araucania
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Temuco, Araucania, Chile, 4810469
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Region Metropolitana
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Santiago de Chile, Region Metropolitana, Chile, 7500836
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Seongnam, Korea, Republic of, 13496
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Seoul, Korea, Republic of, 1812
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Seoul, Korea, Republic of, 3080
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Seoul, Korea, Republic of, 3722
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Seoul, Korea, Republic of, 5505
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Seoul, Korea, Republic of, 6273
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Seoul, Korea, Republic of, 6351
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Yangsan, Korea, Republic of, 50612
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Kuala Lumpur, Malaysia, 59100
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Pulau Pinang, Malaysia, 13200
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 15586
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Kota Bharu, Kelantan, Malaysia, 16150
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Selangor
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Ampang, Selangor, Malaysia, 68000
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Chihuahua, Mexico, 31217
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D.f.
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Mexico City, D.f., Mexico, CP 06760
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Białystok, Poland, 15-027
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Lublin, Poland, 20-090
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Arkhangel'sk, Russian Federation, 163045
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Moscow, Russian Federation, 115478
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Nal'chik, Russian Federation, 360000
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Nizhny Novgorod, Russian Federation, 603006
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Obninsk, Russian Federation, 249036
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Orenburg, Russian Federation, 460021
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Pyatigorsk, Russian Federation, 357502
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Rostov-on-Don, Russian Federation
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Saint Petersburg, Russian Federation, 197758
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Saint Petersburg, Russian Federation, 198255
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Sochi, Russian Federation, 354057
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Ufa, Russian Federation, 450054
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Volgograd, Russian Federation, 400131
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Krasnodar Region
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Krasnodar, Krasnodar Region, Russian Federation, 350040
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11080
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Kragujevac, Serbia, 34000
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Sremska Kamenica, Serbia, 21204
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Barcelona, Spain, 8035
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Barcelona, Spain, 8041
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Barcelona, Spain, 8908
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Córdoba, Spain, 14004
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El Palmar, Spain, 46010
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Elche, Spain, 3203
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Girona, Spain, 17007
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Madrid, Spain, 28046
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Madrid, Spain, 28050
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Málaga, Spain, 29010
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Palma De Mallorca, Spain, 7120
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Palma De Mallorca, Spain, 7198
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Sabadell, Spain, 8208
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Seville, Spain, 41013
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Valencia, Spain, 46009
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Valencia, Spain, 46010
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Zaragoza, Spain, 50009
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Taichung, Taiwan, 40705
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 10630
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Taipei, Taiwan, 11259
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Taoyuan, Taiwan, 3331
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Chernivtsi, Ukraine, 58013
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Dnepropetrovsk, Ukraine, 49102
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Ivano-Frankivs'k, Ukraine, 76018
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Kharkiv, Ukraine, 61070
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Khmelnytskyi, Ukraine, 29009
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Luts'k, Ukraine, 43018
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Poltava, Ukraine, 36011
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Ternopil', Ukraine, 46000
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Vinnytsia, Ukraine, 21029
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Zaporizhzhya, Ukraine
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Alabama
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Mobile, Alabama, United States
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Arizona
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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California
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Duarte, California, United States
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Long Beach, California, United States
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Orange, California, United States
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Orange, California, United States, 92868
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San Francisco, California, United States
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Florida
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Georgia
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Augusta, Georgia, United States
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Illinois
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Maywood, Illinois, United States
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Park Ridge, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa
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Iowa City, Iowa, United States
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Maine
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Scarborough, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Michigan
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Detroit, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Nebraska
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Omaha, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Hackensack, New Jersey, United States
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Newark, New Jersey, United States, 07103
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New York
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Albany, New York, United States, 12208
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Brooklyn, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States, 45219
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Hilliard, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Greenville, South Carolina, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Dallas, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Participants with locally advanced cervical cancer at higher risk for recurrence (HRLACC) received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence.
Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
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Experimental: ADXS11-001
Participants with HRLACC received ADXS11-001 at a dose of 1x10^9 colony forming units (CFU) by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence.
Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Free Survival (DFS)
Time Frame: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
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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.
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From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events
Time Frame: From first dose of study drug until end of study (Up to 44.7 months)
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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.
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From first dose of study drug until end of study (Up to 44.7 months)
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Overall Survival (OS)
Time Frame: From the date of randomization until death due to any cause (Maximum duration: 44.7 months)
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Overall survival was defined as the time from the date of randomization until death due to any cause.
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From the date of randomization until death due to any cause (Maximum duration: 44.7 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas J Herzog, MD, University of Cincinnati
- Principal Investigator: Brian Slomovitz, MD, Sylvester Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADXS001-02
- 2015-004844-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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