Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02899793
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Endometrial Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg (fixed dose) IV every 3 weeks (+/- 3 days) until progression or adverse effects prohibit therapy

Study Details

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).

Key Dates

Start date
Sep 30, 2016
Status verified
May 2025
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Pembrolizumab 200 mg, Q3W, IV Infusion, Day 1 of each 3 week cycle

Primary Outcome Measure

Frequency of Objective Tumor Response as Assessed by RECIST 1.1- Overall Response Rate (ORR) [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510-

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