High Risk Cervical CancerPhase 3AIM2CERVNCT02853604
Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
A Phase 3 study testing ADXS11-001 in people with High Risk Cervical Cancer and Advanced Cervical Cancer, run by Advaxis, Inc. at 117 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Cervical Cancer, Advanced Cervical Cancer
- What is being tested?
- ADXS11-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 117 sitesin 14 countries
- Study dates
- 15 Dec 2015to 31 Jul 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
117 sites in 14 countries.
117 sites in 14 countries
United States41 sites
Study site
Albany, New York, 12208
Study site
Augusta, Georgia
Site
Baltimore, Maryland
Site
Brooklyn, New York
Study site
Charlotte, North Carolina
Study site
Chattanooga, Tennessee
Site
Cincinnati, Ohio, 45219
Site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Duarte, California
Site
Galveston, Texas
Study site
Greenville, South Carolina
Site
Hackensack, New Jersey
Site
Hilliard, Ohio
Study site
Houston, Texas
Site
Indianapolis, Indiana
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Kettering, Ohio
Site
Las Vegas, Nevada
Study site
Long Beach, California
Study site
Maywood, Illinois
Site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Mobile, Alabama
Study site
Nashville, Tennessee
Site
Newark, New Jersey, 07103
Study site
Oklahoma City, Oklahoma
Site
Omaha, Nebraska
Site
Orange, California, 92868
Study site
Orange, California
Site
Park Ridge, Illinois
Study site
Philadelphia, Pennsylvania
Site
Phoenix, Arizona
Study site
Phoenix, Arizona
Site
San Francisco, California
Study site
Scarborough, Maine
Site
Tallahassee, Florida
Study site
Tampa, Florida
Study site
Winston-Salem, North Carolina
Spain17 sites
Site
Barcelona, 8035
Site
Barcelona, 8041
Site
Barcelona, 8908
Site
Córdoba, 14004
Site
El Palmar, 46010
Site
Elche, 3203
Site
Girona, 17007
Site
Madrid, 28046
Site
Madrid, 28050
Site
Málaga, 29010
Site
Palma de Mallorca, 7120
Site
Palma de Mallorca, 7198
Site
Sabadell, 8208
Site
Seville, 41013
Site
Valencia, 46009
Site
Valencia, 46010
Site
Zaragoza, 50009
Russia14 sites
Site
Arkhangelsk, 163045
Site
Krasnodar, Krasnodarskiy Kray, 350040
Site
Moscow, 115478
Site
Nal'chik, 360000
Site
Nizhny Novgorod, 603006
Site
Obninsk, 249036
Site
Orenburg, 460021
Site
Pyatigorsk, 357502
Site
Rostov-on-Don
Site
Saint Petersburg, 197758
Site
Saint Petersburg, 198255
Site
Sochi, 354057
Site
Ufa, 450054
Site
Volgograd, 400131
Ukraine10 sites
Site
Chernivtsi, 58013
Site
Dnipro, 49102
Site
Ivano-Frankivsk, 76018
Site
Kharkiv, 61070
Site
Khmelnytskyi, 29009
Site
Lutsk, 43018
Site
Poltava, 36011
Site
Ternopil, 46000
Site
Vinnytsia, 21029
Site
Zaporizhzhya
South Korea8 sites
Site
Seongnam, 13496
Site
Seoul, 1812
Site
Seoul, 3080
Site
Seoul, 3722
Site
Seoul, 5505
Site
Seoul, 6273
Site
Seoul, 6351
Site
Yangsan, 50612
Taiwan6 sites
Site
Taichung, 40705
Site
Tainan, 704
Site
Taipei, 10002
Site
Taipei, 10630
Site
Taipei, 11259
Site
Taoyuan, 3331
Malaysia5 sites
Site
Ampang, Selangor, 68000
Site
Kota Bharu, Kelantan, 15586
Site
Kota Bharu, Kelantan, 16150
Site
Kuala Lumpur, 59100
Site
Pulau Pinang, 13200
Serbia4 sites
Site
Belgrade, 11000
Site
Belgrade, 11080
Site
Kamenitz, 21204
Site
Kragujevac, 34000
Canada3 sites
SITE
Calgary, Alberta, T2N4N2
SITE
Montreal, Quebec, H2X0A9
Site
Sherbrooke, Quebec, J1H5N4
Brazil2 sites
Site
Natal, Rio Grande do Norte, 59075-740
Site
Rio de Janeiro, Rio de Janeiro, 20220-410
Chile2 sites
SITE
Santiago, Santiago Metropolitan, 7500836
SITE
Temuco, Araucania, 4810469
About this study
Official title: 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.
Read the 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.
- Being tested
- ADXS11-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADXS11-001Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ADXS11-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From first dose of study drug until end of study (Up to 44.7 months)
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization until death due to any cause.
Measured: From the date of randomization until death due to any cause (Maximum duration: 44.7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start15 Dec 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advaxis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853604
- Sponsor's protocol ID
- ADXS001-02
- Other IDs
- 2015-004844-20, 2015
- Acronym
- AIM2CERV
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2016
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36220750
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
- ClinicalTrials.gov ID
- NCT02853604
- Acronym / sponsor ID
- AIM2CERV / ADXS001-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Advaxis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| ADXS11-001 | Experimental | Drug: ADXS11-001Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADXS11-001 | Drug | ADXS11-001 |
| Placebo | Drug | Placebo |
Primary outcome
Disease Free Survival (DFS)
Time frame: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
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.
2 secondary outcomes
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)
Overall Survival (OS)
Time frame: From the date of randomization until death due to any cause (Maximum duration: 44.7 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36220750Alexander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
117 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADXS11-001 in people with High Risk Cervical Cancer and Advanced Cervical Cancer, run by Advaxis, Inc. at 117 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 117 sites in United States, Spain, Russia, Ukraine, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.