At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed endometrial cancer that is recurrent or progressive following at least one prior chemotherapy regimen
- ✓Tumor demonstrates ultramutation (POLE/POLD1-mutation) and/or hypermutation (due to MMR gene defect) by NGS, CGP testing, and/or standard PCR-based DNA microsatellite instability (MSI) and immunohistochemistry (IHC)
- ✓Measurable disease by RECIST 1.1
- ✓ECOG performance status 0 or 1
- ✕Prior therapy with nivolumab, pembrolizumab, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody specifically targeting T-cell co-stimulation or immune checkpoint pathways
- ✕History of severe hypersensitivity reaction to any monoclonal antibody or hypersensitivity to pembrolizumab or its excipients
- ✕Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance
- ✕Known brain or leptomeningeal metastases unless treated with no evidence of progression and no requirement for immunosuppressive corticosteroid doses (>10 mg/day prednisone equivalents)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Evaluation of Pembrolizumab, a Humanized Antibody Against PD-1, in the Treatment of Persistent or Recurrent Hypermutated/Ultramutated Endometrial Cancer Identified by Next Generation Sequencing (NGS) and Comprehensive Genomic Profiling (CGP)
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab for Recurrent Endometrial Cancer. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Primary Objectives: To assess the antitumor activity (proportion of objective response by RECIST 1.1 criteria) of pembrolizumab with objective tumor response in patients with persistent, recurrent or metastatic endometrial cancer harboring an ultra-mutated or hyper-mutated (MMR gene-defective) phenotype identified by next generation sequencing (NGS) and comprehensive genomic profiling (CGP). To determine the nature and degree of toxicity of pembrolizumab as assessed by CTCAE in patients with persistent, recurrent or metastatic endometrial carcinoma. Secondary Objective(s): To estimate the duration of progression-free survival (PFS) and overall survival (OS).
Study Details
Timeline
Interventions
Pembrolizumab 200 mg (fixed dose) IV every 3 weeks (+/- 3 days) until progression or adverse effects prohibit therapy