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

NCT02853604 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: ADXS001-022015-004844-20
• Study Type: interventional
• Target: 110
• Locations: 14 countries
• Sites: 117

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.

Conditions

High Risk Cervical Cancer; Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events

  From first dose of study drug until end of study (Up to 44.7 months)

• Overall Survival (OS)

  From the date of randomization until death due to any cause (Maximum duration: 44.7 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

ADXS11-001

EXPERIMENTAL

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.

Drug: ADXS11-001

Interventions

ADXS11-001 DRUG

ADXS11-001

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advaxis, Inc.: lead
• Gynecologic Oncology Group: collaborator

Study Sites (117)

Unknown Facility

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Duarte, California, United States

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Long Beach, California, United States

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Orange, California, 92868, United States

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Orange, California, United States

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San Francisco, California, United States

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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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Augusta, Georgia, United States

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Maywood, Illinois, United States

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Park Ridge, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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Newark, New Jersey, 07103, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, 45219, United States

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Hilliard, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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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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Milwaukee, Wisconsin, United States

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La Rioja, F5300 COE, Argentina

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Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil

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Natal, Rio Grande do Norte, 59075-740, Brazil

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Calgary, Alberta, T2N4N2, Canada

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Montreal, Quebec, H2X0A9, Canada

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Sherbrooke, Quebec, J1H5N4, Canada

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Temuco, Región de la Araucanía, 4810469, Chile

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Santiago, Santiago Metropolitan, 7500836, Chile

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Kota Bharu, Kelantan, 15586, Malaysia

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Kota Bharu, Kelantan, 16150, Malaysia

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Ampang, Selangor, 68000, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Pulau Pinang, 13200, Malaysia

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Mexico City, D.F., CP 06760, Mexico

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Chihuahua City, 31217, Mexico

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Bialystok, 15-027, Poland

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Lublin, 20-090, Poland

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Krasnodar, Krasnodarskiy Kray, 350040, Russia

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Arkhangelsk, 163045, Russia

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Moscow, 115478, Russia

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Nal'chik, 360000, Russia

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Nizhny Novgorod, 603006, Russia

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Obninsk, 249036, Russia

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Orenburg, 460021, Russia

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Pyatigorsk, 357502, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, 198255, Russia

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Sochi, 354057, Russia

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Ufa, 450054, Russia

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Volgograd, 400131, Russia

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Belgrade, 11000, Serbia

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Belgrade, 11080, Serbia

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Kamenitz, 21204, Serbia

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Kragujevac, 34000, Serbia

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Seongnam, 13496, South Korea

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Seoul, 1812, South Korea

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Seoul, 3080, South Korea

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Seoul, 3722, South Korea

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Seoul, 5505, South Korea

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Seoul, 6273, South Korea

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Seoul, 6351, South Korea

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Yangsan, 50612, South Korea

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Barcelona, 8035, Spain

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Barcelona, 8041, Spain

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Barcelona, 8908, Spain

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Córdoba, 14004, Spain

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El Palmar, 46010, Spain

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Elche, 3203, Spain

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Girona, 17007, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 7120, Spain

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Palma de Mallorca, 7198, Spain

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Sabadell, 8208, Spain

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Seville, 41013, Spain

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Valencia, 46009, Spain

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Valencia, 46010, Spain

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Zaragoza, 50009, Spain

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Taichung, 40705, Taiwan

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Tainan, 704, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 10630, Taiwan

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Taipei, 11259, Taiwan

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Taoyuan District, 3331, Taiwan

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Chernivtsi, 58013, Ukraine

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Dnipro, 49102, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kharkiv, 61070, Ukraine

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Khmelnytskyi, 29009, Ukraine

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Lutsk, 43018, Ukraine

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Poltava, 36011, Ukraine

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Ternopil, 46000, Ukraine

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Vinnytsia, 21029, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (1)

• Alexander LM, van Pijkeren JP. Modes of therapeutic delivery in synthetic microbiology. Trends Microbiol. 2023 Feb;31(2):197-211. doi: 10.1016/j.tim.2022.09.003. Epub 2022 Oct 8.

  PMID: 36220750 DERIVED

Results Point of Contact

• Title: Surya Vangala
• Organization: Advaxis, Inc.

vangala@advaxis.com

609-423-2528

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 3, 2016
• Study Start: December 15, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2); US (41); PL (2); RU (14); SE (4); ES (17); TW (6); KR (8); UA (10); AR (1); BR (2); MY (5); ME (2); CA (3)