drugset / Trial / NCT02164461

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

NCT02164461

Phase 1 Completed 12 enrolled Advaxis, Inc.
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

EvaluationDrugModalityDoseRoute
Subject ADXS11-001 Vaccine 1e+09 unknown Intravenous
Subject ADXS11-001 Vaccine 5e+09 unknown Intravenous
Subject ADXS11-001 Vaccine 1e+10 unknown Intravenous