Bavarian Nordic Announces Start of Randomized Phase 2 Study Comparing PROSTVAC and Chemotherapy versus Chemotherapy

02-Mar-2011 - Denmark

Bavarian Nordic A/S announced the initiation of a new multicenter, randomized Phase 2 study of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with PROSTVAC®. The study will compare PROSTVAC® followed by docetaxel (chemotherapy) versus docetaxel alone.

Patients in the PROSTVAC® arm will receive an accelerated treatment with PROSTVAC® (5 immunizations over 2 months) followed by docetaxel and prednisone. The control arm will receive upfront docetaxel and prednisone. After completion of study therapy, patients are followed up every 3-6 months for 5 years. With the first patients now being enrolled, the study is anticipated to be fully enrolled with 144 patients in 2012.

The primary endpoint of the study is to evaluate the overall survival. Secondary endpoints include the evaluation of prostate-specific antigen (PSA) response rates and evaluation of the association between development of PSA-specific immune responses, time to progression, and overall survival in patients treated with these regimens.

The study is being conducted by The Eastern Cooperative Oncology Group (ECOG) - one of the largest clinical cancer research organizations in the United States. Dr. Doug McNeel (University of Wisconsin) is the Principle Investigator of the study. The DCTD/NCI-sponsored1) study is being conducted under the cooperative research and development agreement (CRADA) that Bavarian Nordic has with the NCI for further development of PROSTVAC®.

https://www.bionity.com/en/news/131105/bavarian-nordic-announces-start-of-randomized-phase-2-study-comparing-prostvac-and-chemotherapy-versus-chemotherapy.html