Spots Global Cancer Trial Database for Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
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Trial Identification
Brief Title: Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
Official Title: 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)
Study ID: NCT02899793
Conditions
Interventions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Yale New Haven Hospital, New Haven, Connecticut, United States
Contact Details
Name: Alessandro D. Santin, M.D
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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