a study on Carcinoma, Intraductal, Noninfiltrating
This is a pilot study to investigate the change in the immune microenvironment of high risk ductal carcinoma in situ (DCIS) after short term exposure to pembrolizumab.
Testing the Ability of Pembrolizumab to Alter the Tumor Immune MicroEnvironment (TIME) of High Risk DCIS
This study will include 3 dose cohorts using a 3+3 cohort dose escalation design (see figure 1) followed by a 4th cohort at the maximum tolerated dose. Unless a dose limiting toxicity (DLT), defined any grade 3 or 4 toxicity, is observed requiring expansion of a cohort or a subject withdraws, 3 subjects will be enrolled into each cohort in the dose escalation phase. Subjects, upon diagnosis with high risk DCIS, will be offered 2 doses of pembrolizumab injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 2nd dose. The subject will then undergo the surgical treatment as determined by the surgeon and the subject (partial mastectomy or mastectomy). The primary objective of this phase of the study will be safety and feasibility of intralesional injection of pembrolizumab. The maximum tolerated dose will be used in the expansion phase. The expansion cohort will have a target enrollment of 30 subjects randomized to either the control group or the treatment group. 10 subjects will be randomized to the control group and 20 subjects will be randomized to the treatment group. The control group will proceed to surgery alone following the diagnosis of high risk DCIS. The treatment group will receive 2 doses of intralesional pembrolizumab 3 weeks apart (+/- 1 week) prior to surgery. All subjects in the expansion cohort will also undergo a baseline MRI at diagnosis and undergo a 2nd MRI prior to surgery. Baseline and pre-surgical MRI images will be evaluated for changes in tumor volume.
Carcinoma, Intraductal, Noninfiltrating Pembrolizumab
Open to females ages 18 years and up
Hepatic Serum total bilirubin <=1.5 xULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels> 1.5 ULN AST (SGOT) and ALT (SGPT) <= 2.5 X ULN Albumin
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