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 : June 21, 2018
|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 2019|
|Estimated Study Completion Date :||September 2019|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872025
|Contact: Laura Essermanemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Laura Esserman||University of California, San Francisco|