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Single Arm - Pembrolizumab for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Endometrial Cancer+1 MorePembrolizumab - Drug
Eligibility
18+
Female
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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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 3 weeks

3 weeks
Change in number of Tumor Infiltrating Lymphocytes by endometrial cancer sub-types
Change in the number of Tumor Infiltrating Lymphocytes
Correlation of Immune and Obesity/Inflammation EC Signatures with TILs
Correlation of Microbiota Profiles with TILs
Correlation of Programmed Cell Death-1 (PD-1) Expression with TILs
Number of patients who experience Adverse Events after one dose of Pembrolizumab
Overall Response Rate of Pembrolizumab with Paclitaxel and Carboplatin

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Single Arm - Pembrolizumab
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Single Arm - Pembrolizumab · No Placebo Group · Phase < 1

Single Arm - PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, Hysterectomy · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Hysterectomy
2017
Completed Phase 3
~1380

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 weeks

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,955,814 Total Patients Enrolled
14 Trials studying Endometrial Cancer
2,968 Patients Enrolled for Endometrial Cancer
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
311 Previous Clinical Trials
81,755 Total Patients Enrolled
9 Trials studying Endometrial Cancer
324 Patients Enrolled for Endometrial Cancer
Victoria Bae-Jump, MDPrincipal InvestigatorUNC-Chapel Hill
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Endometrial Cancer
20 Patients Enrolled for Endometrial Cancer

Eligibility Criteria

Age 18+ · Female Participants · 9 Total Inclusion Criteria

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References

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