Pembrolizumab in High-risk Ductal Carcinoma in Situ (DCIS)
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|ClinicalTrials.gov Identifier: NCT02872025|
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Intraductal, Noninfiltrating||Drug: Pembrolizumab||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Ability of Pembrolizumab to Alter the Tumor Immune MicroEnvironment (TIME) of High Risk DCIS|
|Actual Study Start Date :||December 12, 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Pembrolizumab intralesionally (IL) x 2 doses
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).
No Intervention: No active treatment
The control group will proceed to surgery alone following the diagnosis of high risk DCIS.
- Maximum tolerated dose (MTD) [ Time Frame: 18 months ]To determine the maximum tolerated dose (MTD), and recommended dose for subsequent expansion cohort, of intralesionally administered pembrolizumab in patients with ductal carcinoma in situ (DCIS) of the breast.
- Dose-limiting toxicities (DLTs) [ Time Frame: 18 months ]To define the dose-limiting toxicities (DLTs), tolerability, and feasibility of intralesional administration of pembrolizumab in patients with DCIS.
- Percentage of patients who demonstrate an increase (baseline vs. post intralesional injection) in intralesional CD8+ T cells (treated vs. untreated participants) as measured using multiplex immunofluorescence on FFPE tissue sections [ Time Frame: post intralesional injection ]To determine the response rate to intralesional pembrolizumab in patients with DCIS, as measured by an increase (baseline vs. post treatment) in intralesional CD8+ T cells, compared to untreated controls.
- Tumor volume [ Time Frame: 18 months ]To determine whether intralesional pembrolizumab decreases tumor volume on MRI imaging.
- Exploratory immunological responses to pembrolizumab before and after intralesional injection as measured using multiplex immunofluorescence on FFPE tissue sections [ Time Frame: 18 months ]To characterize changes in the immune landscape of DCIS following intralesional administration of pembrolizumab.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872025
|Contact: Katherine Forsterfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|