NCT03532217

Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

A Pilot Trial of Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study study aims to elucidate the immune responses to a shared antigen vaccine (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the investigators will study the impact of the combination immunotherapy on peripheral T cell activation, as well as immune response in the tumor microenvironment. Finally, the investigators will evaluate the safety and tolerability to this novel personalized immunotherapy in combination with checkpoint blockade.

Conditions

• Metastatic Hormone-Sensitive Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PROSTVAC-V	-Replication-competent vaccinia virus which has been engineered to encode the sequences for a modified human prostate-specific antigen (PSA) and a triad of co-stimulatory molecules (TRICOM)
BIOLOGICAL	PROSTVAC-F	-Fowlpox virus which does not replicate in human cells and has been engineered to encode the same sequences present in PROSTVAC-V.
DRUG	Nivolumab	-Nivolumab is a human monoclonal antibody (mAb)
DRUG	Ipilimumab	-Ipilimumab is a mAb blocking the inhibitory signal mediated by cytotoxic T Lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that downregulates the immune system.
BIOLOGICAL	Neoantigen DNA vaccine	Each DNA vaccination will be 1 mL vaccine administered intramuscularly. At each vaccination time point, patients will receive two injections at separate sites.
DEVICE	TriGrid Delivery System	-Electroporation device
PROCEDURE	Tumor biopsy	-Pre-treatment, post-treatment A (optional), and end of treatment
PROCEDURE	Peripheral blood	-At the time of pre-treatment biopsy, mid-treatment of chemo-ADT, at time of enrollment (prior to POSTVAC administration), mid-treatment A, mid-treatment B (multiple)
PROCEDURE	Fecal samples	-Post chemo/pre-treatment A, post-treatment A, pre-treatment B, post-treatment B
PROCEDURE	Leukapheresis	* Post-treatment A/pre-treatment B * Mid-Treatment B, after Cycle 9 Day 1 and prior to Cycle 10 Day 1 * End of treatment

Timeline

• Start date: 2018-09-14
• Primary completion: 2022-04-01
• Completion: 2022-07-25
• First posted: 2018-05-22
• Last updated: 2022-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study