MVI-816

P1, N=14, Not yet recruiting, University of Wisconsin, Madison

The presence of T-cells specific for the PAP target antigen was detectable in 6/10 (60%) individuals with nmCSPC, and 3/5 (60%) individuals with nmCRPC, many years after immunization. The detection of immune responses to the vaccine target years after immunization suggests durable immunity can be elicited in patients using a DNA vaccine encoding a tumor-associated antigen.Trial Registration: NCT00582140 and NCT00849121.

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2024 --> Dec 2027

P2, N=61, Active, not recruiting, University of Wisconsin, Madison | Recruiting --> Active, not recruiting

P2, N=60, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2025 --> Oct 2026 | Trial primary completion date: Mar 2024 --> Jan 2025

In this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to disease progression, but did not eradicate disease. Quantitative imaging suggested that additional treatments targeting mechanisms of resistance may be required to eliminate tumors.

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2023 --> Nov 2024

P2, N=60, Recruiting, University of Wisconsin, Madison | Trial primary completion date: Dec 2023 --> Mar 2024

P1/2, N=66, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Jan 2025 --> Nov 2023 | Trial primary completion date: Jan 2024 --> Dec 2022

P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Oct 2023 --> Jan 2025 | Trial primary completion date: Oct 2022 --> Jan 2024

Findings here demonstrate that combining programmed cell death 1 blockade with MVI-816 is safe, can augment tumor-specific T cells, and can result in a favorable 6-month disease control rate. Correlative studies suggest T-cell activation by vaccination is critical to the mechanism of action of this combination. Future randomized clinical trials are needed to validate these findings.