Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

Phase 2 Completed 54 enrolled Gynecologic Oncology Group Advaxis, Inc. · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects and how well vaccine therapy works in treating patients with cervical cancer that does not go to remission despite treatment (persistent) or has come back (recurrent). Vaccines therapy may help the body build an effective immune response to kill tumor cells.

Timeline

Start: 2011-05-23
Primary completion: 2018-10-02
Completion: 2018-10-02

Outcome

Met primary endpoint

paper ADXS-HPV immunotherapy was tolerable and met the protocol-specified benchmark for activity required to warrant further investigation in volunteers with cervical carcinoma. PMID 32641240 ↗

Publications

Huh WK, Brady WE, Fracasso PM, Dizon DS, Powell MA, Monk BJ, Leath CA 3rd, Landrum LM, Tanner EJ, Crane EK, Ueda S, McHale MT, Aghajanian C. Phase II study of axalimogene filolisbac (ADXS-HPV) for platinum-refractory cervical carcinoma: An NRG oncology/gynecologic oncology group study. Gynecol Oncol. 2020 Sep;158(3):562-569. doi: 10.1016/j.ygyno.2020.06.493. Epub 2020 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADXS11-001	Vaccine	1e+09 unknown	Intravenous