Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02164461 · ClinicalTrials.gov registry record · Phase 1
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
A Phase 1 study, sponsored by Advaxis.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02164461: Completed Phase 1 study, sponsored by Advaxis.
NCT02164461 is a Phase 1 study that has completed, run by Advaxis. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02164461, a Phase 1 study, has completed, sponsored by Advaxis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy. Hematologic: 1. Grade 4 hematologic toxicity. 2. Febrile neutropenia, defined as absolute neutrophil count (ANC) \< 1000/mm\^3 with a single temperature of \>38.3° C (101° F) or a sustained temperature of \>38° C (100.4° F) for more than 1 hour. 3. Grade 3 thrombocytopenia lasting \>72 hours. 4. Grade 4 thrombocytopenia. Non-Hematologic: 1. ≥Grade 3 non-hematologic t
Interventions
- BIOLOGICAL Axalimogene filolisbac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-03-04 |
| Est. Completion | 2017-03-08 |
| Phase | Phase 1 |
What the finished NCT02164461 record still lists
NCT02164461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Axalimogene filolisbac is the first listed.
NCT02164461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02164461 about?
NCT02164461 is a clinical study titled "Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer". 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 adenocarcino...
What is the current status of trial NCT02164461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-03-04. Estimated completion is 2017-03-08.
What interventions are being tested in trial NCT02164461?
The interventions under investigation include: Axalimogene filolisbac (BIOLOGICAL).
Who is sponsoring clinical trial NCT02164461?
This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02164461's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI