Window of Opportunity Study of Pembrolizumab in Early Stage, High Grade Obesity-driven Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03694834|
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Uterine Cancer||Drug: Pembrolizumab Procedure: Hysterectomy||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Window of Opportunity Study of Pembrolizumab in Early Stage, High Grade Obesity-driven Endometrial Cancer|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: Single Arm - Pembrolizumab
Single dose of Pembrolizumab 200mg IV administered prior to hysterectomy and surgical staging.
A single dose of Pembrolizumab (200 mg) will be administered IV over 30 min (-5 /+10 min) approximately 3 weeks prior to the scheduled hysterectomy.
Pembrolizumab (200 mg) will be administered IV over 30 min (-5/+10 min) every three weeks in combination with paclitaxel and carboplatin as adjuvant therapy over 6 cycles. Pembrolizumab should be given on D1 of each cycle after the infusion of cytotoxics.
Other Name: Keytruda
Hysterectomy/Surgical Staging per institutional standard of care.
- Change in the number of Tumor Infiltrating Lymphocytes [ Time Frame: 3 weeks ]Change in number of tumor-infiltrating lymphocytes in response to single dose of pembrolizumab will be determined by performing histopathologic analysis of H&E-stained tumor sections collected at baseline and at the time of surgery.
- Number of patients who experience Adverse Events after one dose of Pembrolizumab [ Time Frame: 3 weeks ]The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
- Change in number of Tumor Infiltrating Lymphocytes by endometrial cancer sub-types [ Time Frame: 3 weeks ]Count and compare associations of (1) pre-treatment Tumor Infiltrating Lymphocyte (TIL) numbers (2) clonality of TILs and (3) change in number and phenotype of TILs with pembrolizumab treatment between Microsatellite Instability (MSI) and DNA Polymerase ε Endometrial Cancers (EC) versus MSI low/stable ECs versus Copy Number High ECs.
- Correlation of Programmed Cell Death-1 (PD-1) Expression with TILs [ Time Frame: 3 weeks ]Compare possible associations of PD-1, Programmed Death Ligand 1 (PD-L1) and Programmed Death Ligand 2 (PD-L2) messenger Ribonucleic Acid (mRNA) expression with (1) pre-treatment TIL numbers (2) clonality of TILs and (3) change in number and phenotype of TILs.
- Correlation of Immune and Obesity/Inflammation EC Signatures with TILs [ Time Frame: 3 weeks ]Compare possible associations of immune and obesity/inflammation EC signatures with (1) Body Mass Index (BMI) (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs.
- Correlation of Microbiota Profiles with TILs [ Time Frame: 3 weeks ]Compare possible associations of gut, vaginal and uterine microbiota profiles with (1) BMI (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs.
- Overall Response Rate of Pembrolizumab with Paclitaxel and Carboplatin [ Time Frame: 3 weeks ]
Calculate the overall response rate of pembrolizumab in combination with paclitaxel and carboplatin following hysterectomy and surgical staging in (1) stage I/II, serous/clear cell EC and (2) stage III, Grade 3 (serous, clear cell or endometrioid histologies) EC.
Response is measured as:
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis <10mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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): NCT03694834
|Contact: Jennifer Gruhnfirstname.lastname@example.org|
|Contact: Katie Lansingemail@example.com|
|Principal Investigator:||Victoria Bae-Jump, MD||UNC-Chapel Hill|