Pembrolizumab, Paclitaxel and Carboplatin for Advanced or Recurrent Endometrial Cancer
This study aims to evaluate the effectiveness of Pembrolizumab, Paclitaxel and Carboplatin combination in improving progression-free survival in patients with advanced or recurrent endometrial cancer.
Carboplatin
+ Computed Tomography
+ Paclitaxel
Urogenital Diseases+14
+ Genital Diseases
+ Carcinosarcoma
Treatment Study
Summary
Study start date: August 22, 2019
Actual date on which the first participant was enrolled.This study is exploring the effectiveness of a drug called Pembrolizumab (MK-3475) when combined with standard chemotherapy treatments, Paclitaxel and Carboplatin, for women with advanced or recurrent endometrial cancer. The primary goal is to see if adding Pembrolizumab to the standard treatment can improve outcomes for these patients. The study is particularly interested in understanding how this combination therapy works for different types of endometrial cancer, specifically those with mismatch repair protein proficient (pMMR) or mismatch repair deficiency (dMMR). This research is important as it could potentially lead to improved treatments and better quality of life for women with advanced or recurrent endometrial cancer. During the study, participants are randomly assigned to one of two groups. One group receives the standard chemotherapy treatments along with a placebo, while the other group receives the same chemotherapy treatments but with Pembrolizumab instead of the placebo. Both groups receive their treatments every three weeks for six cycles, with the possibility of extending to ten cycles if necessary. After the initial treatment phase, participants enter a maintenance phase where they continue to receive either the placebo or Pembrolizumab every six weeks for up to 14 cycles. Throughout the study, participants undergo regular CT scans to monitor their progress. The study measures the effectiveness of the treatments by looking at progression-free survival rates, the nature and frequency of side effects, and the impact on patients' physical function and quality of life.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.813 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 397 locations
University of Alabama at Birmingham Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Cancer Center in Google MapsAlaska Women's Cancer Care
Anchorage, United StatesCTCA at Western Regional Medical Center
Goodyear, United StatesNEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, United States