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Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer

NCT02164461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-05-20

Study results available
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Summary

To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10\^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Conditions

  • Effects of Immunotherapy
  • Metastatic/Recurrent Cervical Cancer
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Cervical Small Cell Carcinoma
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer

Interventions

BIOLOGICAL

Axalimogene filolisbac

Sponsors & Collaborators

  • Advaxis, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-04
Primary Completion
2017-03-08
Completion
2017-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02164461 on ClinicalTrials.gov