SLATE-KRAS

P1, N=210, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

P1, N=210, Not yet recruiting, National Cancer Institute (NCI)

P1/2, N=39, Completed, Gritstone bio, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Mar 2023 | Trial primary completion date: Dec 2023 --> Mar 2023

ARMS/HRMA has higher sensitivity and accuracy than SS to assess KRAS mutations in PDAC tumor and plasma samples, with additional advantages of fastness and lower cost. KRAS mutations detected with ARMS/HRMA in tumor and ctDNA, respectively, were associated with lower OS and PFS in surgical and palliative patients. Considering that inhibitors for specific KRAS mutations are becoming available, this strategy may help to perform precision medicine in these highly aggressive cancers.

P1/2, N=39, Active, not recruiting, Gritstone bio, Inc. | Recruiting --> Active, not recruiting | N=144 --> 39

P1/2, N=144, Recruiting, Gritstone bio, Inc. | Trial primary completion date: Dec 2022 --> Dec 2023

Pts receive an adenovirus prime followed by boosts with a self-amplifying mRNA with IV nivolumab 480 mg Q4W +/- SC ipilimumab 30 mg with vaccinations. The most common (>20%) treatment-related adverse events (TRAEs) were low grade, transient pyrexia, fatigue, nausea, injection-site reactions, vomitting, and chills and consistent across V1 and V2. Conclusions This off-the-shelf, neoantigen-specific vaccine demonstrated promising anti-tumor activity in pts with advanced solid tumors with tumor regression and/or molecular response.