990 Participants Needed

Pembrolizumab + Chemotherapy/Radiotherapy for Endometrial Cancer

Recruiting at 237 trial locations
TF
Overseen ByToll Free Number
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

MD

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

I am fully active or restricted in physically strenuous activity but can do light work.
I haven't had any treatments, including radiation or drugs, for my endometrial cancer.
I have provided a tissue sample from my current diagnosis for testing.
See 4 more

Exclusion Criteria

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
I have a type of uterine sarcoma, but not adenosarcoma.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab or placebo in combination with adjuvant chemotherapy, with optional radiotherapy

36 weeks
12 visits (in-person)

Radiotherapy (optional)

Participants may receive radiotherapy starting within 6 weeks of completion of chemotherapy

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 54 months

What Are the Treatments Tested in This Trial?

Interventions

  • Brachytherapy
  • Cisplatin
  • Docetaxel
  • External Beam Radiotherapy (EBRT)
  • Paclitaxel
  • Pembrolizumab
Trial Overview The study tests pembrolizumab combined with adjuvant chemotherapy versus placebo plus chemotherapy in patients who may also receive radiotherapy. The goal is to see if pembrolizumab improves disease-free survival (DFS) and overall survival (OS) compared to the placebo when both are added to standard chemotherapy after surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + ChemotherapyExperimental Treatment8 Interventions
Group II: Placebo + ChemotherapyPlacebo Group8 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

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 profile image

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

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Trials
4
Recruited
2,900+

Gynecologic Oncology Group

Collaborator

Trials
251
Recruited
65,400+

Published Research Related to This Trial

Pembrolizumab (Keytruda) is approved for treating advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, specifically for patients whose disease has progressed after previous treatments.
This approval is significant for patients who are not candidates for curative surgery or radiation, providing a new therapeutic option for a challenging stage of cancer.
New Approved Use for Keytruda.Aschenbrenner, DS.[2022]
In the KEYNOTE-158 study, pembrolizumab showed a clinically meaningful objective response rate in patients with advanced MSI-H/dMMR endometrial cancer, with 84 out of 90 patients completing health-related quality of life (HRQoL) assessments.
Patients receiving pembrolizumab experienced significant improvements in their quality of life, with mean scores on the QLQ-C30 and EQ-5D-3L questionnaires increasing notably, especially among those who achieved a complete or partial response to treatment.
Health-related quality of life with pembrolizumab monotherapy in patients with previously treated advanced microsatellite instability high/mismatch repair deficient endometrial cancer in the KEYNOTE-158 study.O'Malley, DM., Bariani, GM., Cassier, PA., et al.[2022]
In a study of 44 women with advanced or recurrent MMRd/MSI-H endometrial adenocarcinomas treated with pembrolizumab, obesity (BMI≥30) was linked to a higher disease control rate (85.2%) compared to those with a BMI<30 (59.8%).
Patients with obesity also experienced significantly longer progression-free survival (PFS) while overall survival (OS) rates remained similar regardless of BMI, suggesting that body weight may influence treatment outcomes with pembrolizumab.
Obesity is associated with improved progression-free survival in Microsatellite-Instability-High endometrial cancer treated with pembrolizumab.Bernard, L., How, JA., Patel, S., et al.[2023]

Citations

New Approved Use for Keytruda. [2022]
Health-related quality of life with pembrolizumab monotherapy in patients with previously treated advanced microsatellite instability high/mismatch repair deficient endometrial cancer in the KEYNOTE-158 study. [2022]
Obesity is associated with improved progression-free survival in Microsatellite-Instability-High endometrial cancer treated with pembrolizumab. [2023]
Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study. [2023]
Pembrolizumab as a single agent for patients with MSI-H advanced endometrial carcinoma. [2022]
Real-world experience of pembrolizumab and lenvatinib in recurrent endometrial cancer: A multicenter study in Korea. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Clinical and Biological Activity of Chemoimmunotherapy in Advanced Endometrial Adenocarcinoma: A Phase II Trial of the Big Ten Cancer Research Consortium. [2023]
Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. [2023]
Case report: Durable response after pembrolizumab in combination with radiation - induced abscopal effect in platinum - refractory metastatic endometrial clear cell carcinoma. [2023]
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