A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers
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|ClinicalTrials.gov Identifier: NCT02728830|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Results First Posted : July 9, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Neoplasms Epithelial Ovarian Cancer Uterine Endometrial Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Pembrolizumab||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Investigating the Effect of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers of Mullerian Origin|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||December 2020|
Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.
If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.
If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.
Pembrolizumab 200mg IV
Other Name: Keytruda
- Change in Tumor Immune Infiltrates as Measured by PD-L1 Modified H-Score [ Time Frame: Baseline and 14-21 Days ]
This outcome measures the change in tumor immune infiltrates post-pembrolizumab versus pre-pembrolizumab as measured by the PD-L1 Modified H-score.
Histological score (H-score) is a score that is comprised of intensity and percentage of staining and is used for assessing amount of protein (in this case PD-L1) present in a tissue sample. H-score is determined by adding of the percentages of cell staining at each intensity level multiplied by the membrane intensity of staining (0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+(strong staining)).
The H-score has a range of 0 to 300. Lower H-scores represent lower expression of PD-L1 in the tumor sample, while higher scores represent stronger expression of PD-L1 in the tumor samples.
- Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE [ Time Frame: 18 months ]Frequency and severity of adverse events associated with pembrolizumab when given to patients with newly diagnosed gynecologic cancers of müllerian origin prior to standard surgical therapy and as maintenance therapy after completion of chemotherapy. All events experienced within the AE reporting time frame deemed probably, possibly, or definitely related to study drug above the reporting threshold of 4%. Categorized by grade and frequency, defined using CTCAE 4.0 event name and grading.
- Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile [ Time Frame: Baseline and 14-21 Days ]To characterize changes in the tumoral and circulating blood immunoprofile after administration of pembrolizumab. Levels of immune and inflammatory mediators, profile of tumor immune infiltrates, and the expression of PD-L1 in pre-administration samples will be compared to post-administration surgical resection (including ascites) samples.
- Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile for Those Who Enroll in Second Course Phase at Time of Recurrence [ Time Frame: 18 months ]To evaluate changes in the tumoral and circulating blood immunoprofile at time of recurrence. Levels of immune and inflammatory mediators, profile of tumor immune infiltrates, and the expression of PD-L1 in samples at time of recurrence will be compared to pre-administration and surgical samples.
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): NCT02728830
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Angeles A Secord, MD||Duke University|