Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer
Status:
Terminated
Trial end date:
2020-04-22
Target enrollment:
Participant gender:
Summary
This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or
the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized
prostate cancer. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A),
ipilimumab monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm
C), prior to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the
primary vaccine on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F
subcutaneous administrations, given 3 weeks apart. In arms B and C, ipilimumab will be
administered twice, at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab
administration will coincide with the PROSTVAC-F administration. In arm B, ipilimumab will
begin on Day 1. In all three arms, radical prostatectomy (RP) will occur 21 days, or three
weeks, following final treatment administration of PROSTVAC or ipilimumab. No further therapy
will be administered on study following RP.
Phase:
Phase 2
Details
Lead Sponsor:
Lawrence Fong University of California, San Francisco