Perioperative Atezolizumab With MVA-BN-Brachyury and PROSTVAC For Intermediate-Risk And High-Risk Localized Prostate Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 20, 2019

Primary Completion Date

April 9, 2021

Study Completion Date

April 9, 2021

Conditions
Prostate Adenocarcinoma
Interventions
COMBINATION_PRODUCT

MVA-BN-Brachyury

"Cycle= 21 days. Neoadjuvant Therapy: Treatment will be given for 2 neoadjuvant cycles. MVA-BN-Brachyury will be administered as intratumoral injection on Day 1 of each of 2 neoadjuvant cycles. PROSTVAC-V will be administered as a subq injection on Day 1 of Cycle 1 (the first neoadjuvant cycle) and PROSTVAC-F will be administered as a subq injection on Day 1 of Cycle 2 (the second neoadjuvant cycle). Atezolizumab will be given as an infusion on Day 1 of each 2 neoadjuvant cycles.~MVA-BN-Brachyury will be injected intratumorally into the prostate. Injections will target PI-RADS 4 and 5 lesions.~Surgery: Patients will undergo SOC radical prostatectomy Adjuvant Therapy: Systemic treatment with atezolizumab and PROSTVAC-F will be reinitiated between 3 to 8 weeks after surgery and will continue for an additional 6 cycles. PROSTVAC-F will be given as a subq injection on Day 1 of each cycle. Atezolizumab will be given as an infusion on Day 1 of each cycle."

Trial Locations (1)

84112

Huntsman Cancer Institute, Salt Lake City

Sponsors
All Listed Sponsors
collaborator

Bavarian Nordic

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

University of Utah

OTHER