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Immunotherapy vs Chemotherapy for Endometrial Cancer
Study Summary
This trial is testing whether the immunotherapy drug pembrolizumab is better than the standard chemotherapy treatment for women with endometrial cancer that is resistant to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 1274 Patients • NCT02220894Trial Design
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Media Library
- I have had treatment for advanced or metastatic endometrial cancer.I am still recovering from a major surgery.I have an immune system disorder or I'm on specific treatments.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.My endometrial cancer has normal mismatch repair function.I have active brain metastases or carcinomatous meningitis.I am currently being treated for an infection.I have been treated for an autoimmune disease in the last 2 years.I have received an organ or tissue transplant from another person.I am positive for Hepatitis B but have been treated and now have an undetectable viral load.My cancer can be seen and measured on scans.I have esophageal cancer and have only had specific prior treatments like chemotherapy, radiation, or hormonal therapy.I have a uterine sarcoma, but not adenosarcoma or neuroendocrine tumor.I have not received a live vaccine recently.I have been treated with specific drugs that help my immune system fight cancer.I am eligible for surgery or radiotherapy aimed at curing my condition.I have been diagnosed with HIV.My cancer is a type of advanced or recurrent endometrial carcinoma or carcinosarcoma confirmed to be dMMR.I am fully active or restricted in physically strenuous activity but can do light work.I have or had lung inflammation that needed steroids.I had Hepatitis C but now have no detectable virus.I can provide a tissue sample from my tumor for testing.
- Group 1: Carboplatin+paclitaxel
- Group 2: Pembrolizumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities for people to join this experiment?
"The clinical trial is still recruiting patients, as reflected on clinicaltrials.gov. This study was originally posted on February 3rd, 2022 and was most recently edited on October 17th, 2022."
For what purpose is pembrolizumab most commonly prescribed?
"Pembrolizumab is the go-to medication for treating this disease. That said, pembrolizumab has also shown efficacy in treating hodgkin disease, metastatic cutaneous squamous cell carcinoma, and head."
Could you please provide a brief overview of other research on pembrolizumab?
"City of Hope Comprehensive Cancer Center first began studying pembrolizumab in 1997 and, to date, 3018 studies have been completed. Currently, there are 2574 open trials recruiting patients with a large concentration of these studies taking place in Detroit, Michigan."
Are there different hospitals or research centers testing this new treatment within the state?
"Currently, 34 patients are involved in this study. The locations include Karmanos Cancer Institute ( Site 0029) in Detroit, University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008) in Worcester, and University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034) in Pittsburgh. In addition, there are 31 other sites."
What does this clinical trial hope to accomplish?
"The primary objective of this study, which will be measured over a time frame of up to approximately 30 months, is overall survival. In addition, this study will be measuring secondary outcomes including objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigator."
How many individuals are being accepted into this clinical trial?
"In total, this clinical trial needs 350 participants that fit the pre-specified inclusion criteria. These patients can come from different locations, such as Karmanos Cancer Institute ( Site 0029) in Detroit, Michigan and University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008) in Worcester, Massachusetts."
What have been the most common side effects experienced by patients who have taken pembrolizumab?
"Pembrolizumab is considered safe based on our team's criteria. This is a Phase 3 trial, which means that not only is there some data supporting efficacy, but there are also multiple rounds of data supporting safety."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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