Study of PAT in Patients With Solid Tumor Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be seropositive for CMV and EBV.
Must have at least one HLA-A*0201 allele. This screening can be performed after determining CMV and EBV seropositivity is established or, if available, from the results of previous tumor profiling by any CLIA-certified lab (i.e. Caris, FoundationOne).
18 years or older at the time of signing the pre-screening consent.
ECOG Performance Status 0 or 1.
Disqualifiers
Pregnant or breast feeding.
Requires therapeutic anticoagulation for which it is deemed unsafe to discontinue anticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1
Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
Known active CNS metastases
Trial design
Design model
Single group
Treatments tested in this trial
Peptide Alarm Therapy (PAT)
DrugPAT 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.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Peptide Alarm Therapy + PembrolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum 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)Secondary outcomes
1
Progression free survival (PFS)
Kaplan-Meier curves will be used to estimate with a 95% confidence interval.
Time frame
6 MonthsSponsors and contacts
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Source ClinicalTrials.gov