drugset / Trial / NCT02164461
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2015-03-04
- Primary completion
- 2017-03-08
- Completion
- 2017-03-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADXS11-001 | Vaccine | 1e+09 unknown | Intravenous |
| Subject | ADXS11-001 | Vaccine | 5e+09 unknown | Intravenous |
| Subject | ADXS11-001 | Vaccine | 1e+10 unknown | Intravenous |