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ADXS11-001 for Cervical Cancer (AIM2CERV Trial)

Phase 3

Waitlist Available

Led By Thomas J Herzog, MD

Research Sponsored by Advaxis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug until end of study (up to 44.7 months)

Awards & highlights

AIM2CERV Trial Summary

This trial is testing a new treatment for patients with a high risk of their cervical cancer coming back or spreading. The treatment is given after standard chemotherapy and radiation therapy, and the goal is to improve disease-free survival.

Eligible Conditions

Cervical Cancer

AIM2CERV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug until end of study (up to 44.7 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug until end of study (up to 44.7 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until end of study (up to 44.7 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival (DFS)

Secondary outcome measures

Number of Participants With Treatment Emergent Adverse Events

Overall Survival (OS)

AIM2CERV Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ADXS11-001Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axalimogene filolisbac

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Advaxis, Inc.Lead Sponsor

12 Previous Clinical Trials

437 Total Patients Enrolled

Gynecologic Oncology GroupNETWORK

250 Previous Clinical Trials

71,276 Total Patients Enrolled

Thomas J Herzog, MDPrincipal InvestigatorUniversity of Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other ADXS11-001 clinical trials have taken place?

"As of right now, there are two ADXS11-001 trials being conducted. One of those trials is in Phase 3. Most of the research for ADXS11-001 is conducted in Albany, New york, but there are 102 other locations running similar trials."

Answered by AI

What other similar studies has this research been compared to?

"ADXS11-001 has been under clinical investigation since 2016. The first study, which was sponsored by Advaxis, Inc., was completed in 2016 and involved 450 patients. After the successful completion of the initial study, ADXS11-001 received its Phase 3 drug approval. Currently, there are 2 active trials for ADXS11-001 being conducted in 49 cities across 14 countries."

Answered by AI

When might ADXS11-001 be available for public use?

"There is both animal and human data supporting the safety of ADXS11-001, leading to it receiving a score of 3."

Answered by AI

How many individuals are being cared for in this experiment?

"This particular study is no longer searching for volunteers. However, as of 8/10/2020, there were 326 other clinical trials for high risk cervical cancer patients and 2 ADXS11-001 studies still recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02853604.