This is a single center Phase I study with extension of peptide alarm therapy (PAT) administered by intratumoral (IT) injection during the 1st course of a standard of care intravenous PD-1/PD-L1 inhibitor for the treatment of locally advanced or metastatic solid tumor cancers that has failed to be controlled after one or more prior therapies including a previous PD-1/PD-L1 inhibitor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
PAT is given on Day 1 by IT injection after the 1st anti PD-1/PD-L1 infusion and again 36-48 hours later on Day 3.
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGMaximum tolerated dose (MTD) of peptide alarm therapy (PAT)
Use CTCAE v5 criteria to count toxicities per patient including proportions and their 95% confidence intervals will be calculated
Time frame: End of Treatment (typically at day 43)
Progression free survival (PFS)
Kaplan-Meier curves will be used to estimate with a 95% confidence interval.
Time frame: 6 Months
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