Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT02899793|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Endometrial Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2028|
Pembrolizumab 200 mg, Q3W, IV Infusion, Day 1 of each 3 week cycle
Pembrolizumab 200 mg (fixed dose) IV every 3 weeks (+/- 3 days) until progression or adverse effects prohibit therapy
Other Name: MK-3475
- Frequency of objective tumor response as assessed by RECIST 1.1 [ Time Frame: 24 months ]RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
- Frequency and severity of adverse events as assessed by CTCAE v4 [ Time Frame: 24 months ]Common Terminology Criteria for Adverse Events (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
- Duration of progression-free survival (PFS) [ Time Frame: 24 months ]Progression-free survival is defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.
- Overall survival (OS) [ Time Frame: 24 months ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899793
|United States, Connecticut|
|Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Alessandro D. Santin, M.D||Yale University|