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PD-1 Inhibitor
Single Arm - Pembrolizumab for Endometrial Cancer
Phase < 1
Waitlist Available
Led By Victoria Bae-Jump, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Study Summary
This trial is testing whether the addition of pembrolizumab to standard adjuvant chemotherapy improves outcomes for patients with endometrial cancer.
Eligible Conditions
- Endometrial Cancer
- Uterine Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the number of Tumor Infiltrating Lymphocytes
Secondary outcome measures
Change in number of Tumor Infiltrating Lymphocytes by endometrial cancer sub-types
Correlation of Immune and Obesity/Inflammation EC Signatures with TILs
Correlation of Microbiota Profiles with TILs
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm - PembrolizumabExperimental Treatment2 Interventions
Single dose of Pembrolizumab 200mg IV administered prior to hysterectomy and surgical staging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Hysterectomy
2021
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,066,093 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,540 Patients Enrolled for Endometrial Cancer
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
353 Previous Clinical Trials
90,410 Total Patients Enrolled
9 Trials studying Endometrial Cancer
327 Patients Enrolled for Endometrial Cancer
Victoria Bae-Jump, MDPrincipal InvestigatorUNC-Chapel Hill
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Endometrial Cancer
32 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You have had lung inflammation in the past that needed steroids, or you currently have lung inflammation.You have been diagnosed with advanced stage cancer of the uterus, specifically endometrioid, serous, clear cell, or carcinosarcoma types. You are planning to receive chemotherapy before any other treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm - Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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