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

NCT02853604 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-03-14

Study results available
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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

Interventions

DRUG

ADXS11-001

DRUG

Placebo

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • Advaxis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853604 on ClinicalTrials.gov