Pembrolizumab + Chemotherapy/Radiotherapy for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or any form of immunosuppressive therapy, you may need to stop or adjust it before starting the trial.
Is the combination of pembrolizumab and chemotherapy/radiotherapy safe for treating endometrial cancer?
Pembrolizumab, used alone or with other treatments, has shown some side effects, including pneumonitis (lung inflammation) in 1%-5% of patients. However, it is generally considered less toxic than traditional chemotherapy, and studies have evaluated its safety in combination with other drugs for endometrial cancer.12345
How is the drug pembrolizumab different from other treatments for endometrial cancer?
Pembrolizumab is unique because it is an immunotherapy drug that helps the immune system fight cancer cells, and it is used in combination with chemotherapy or radiotherapy for advanced endometrial cancer. It is particularly effective for tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), which are specific genetic features of some cancers.15678
What data supports the effectiveness of pembrolizumab for endometrial cancer?
Research shows that pembrolizumab, when used alone, has been effective in treating advanced endometrial cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), with studies like KEYNOTE-158 demonstrating significant antitumor activity and improved quality of life for patients.127910
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for individuals with newly diagnosed endometrial cancer who've had surgery with curative intent and are at high risk of recurrence. They must be disease-free post-surgery, have not received prior radiation or systemic therapy, and have good performance status (ECOG 0 or 1). Participants need adequate organ function and cannot have certain conditions like active infections, known HIV/Hepatitis B/C infection, autoimmune diseases requiring recent treatment, or a history of severe reactions to the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab or placebo in combination with adjuvant chemotherapy, with optional radiotherapy
Radiotherapy (optional)
Participants may receive radiotherapy starting within 6 weeks of completion of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brachytherapy
- Cisplatin
- Docetaxel
- External Beam Radiotherapy (EBRT)
- Paclitaxel
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
European Network for Gynaecological Oncological Trial Groups
Collaborator
Gynecologic Oncology Group
Collaborator