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Checkpoint Inhibitor
Pembrolizumab + Chemotherapy/Radiotherapy for Endometrial Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants
Has not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 54 months
Awards & highlights
Study Summary
This trial is testing if adding the immunotherapy drug pembrolizumab to standard chemotherapy and radiation improves disease-free survival and overall survival in patients with non-small cell lung cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin rash, hormone gland issues (like thyroid dysfunction), infusion reactions; fatigue; digestive disturbances; blood cell count changes; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a tissue sample from my current diagnosis for testing.
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I haven't had any treatments, including radiation or drugs, for my endometrial cancer.
Select...
My cancer surgery shows I'm at high risk of the cancer coming back.
Select...
I am currently free of cancer both at the original site and elsewhere in my body.
Select...
I have a new diagnosis of Endometrial Carcinoma or Carcinosarcoma and had surgery to remove my uterus and ovaries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 54 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence
Overall Survival (OS)
Secondary outcome measures
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score
+7 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + ChemotherapyExperimental Treatment8 Interventions
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.
Group II: Placebo + ChemotherapyPlacebo Group8 Interventions
Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Brachytherapy
2007
Completed Phase 3
~2100
Paclitaxel
2011
Completed Phase 4
~5380
Docetaxel
1995
Completed Phase 4
~5620
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,832 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,784 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,581 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,143 Patients Enrolled for Endometrial Cancer
European Network for Gynaecological Oncological Trial GroupsUNKNOWN
2 Previous Clinical Trials
1,980 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have a type of uterine sarcoma, but not adenosarcoma.My endometrial cancer is early stage and does not have abnormal p53.I haven't had any treatments, including radiation or drugs, for my endometrial cancer.I had another cancer but was treated successfully with no signs of cancer for 3 years.I have not received a live vaccine in the last 30 days.I have provided a tissue sample from my current diagnosis for testing.I have a history of Hepatitis B or active Hepatitis C.I have been treated with specific immune therapy for cancer.I cannot take carboplatin or paclitaxel due to health reasons.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am currently being treated for an infection.My organs are functioning well.My cancer surgery shows I'm at high risk of the cancer coming back.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have experienced negative reactions to the treatment being studied or any of its ingredients.I have a known history of HIV.I have received an organ or tissue transplant from another person.I have had or currently have lung inflammation treated with steroids.My cancer has a POLE mutation.I still have some tumor left after surgery.I am currently free of cancer both at the original site and elsewhere in my body.My endometrial cancer has come back.I am still recovering from recent surgery and its complications.I have a new diagnosis of Endometrial Carcinoma or Carcinosarcoma and had surgery to remove my uterus and ovaries.You are currently breastfeeding a baby.My condition is FIGO Stage IVB, even if surgery shows no signs of disease.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Chemotherapy
- Group 2: Placebo + Chemotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most common indications for Pembrolizumab?
"Pembrolizumab is an immunotherapy treatment that can be used to fight hodgkin disease, disease, and metastatic cutaneous squamous cell carcinoma."
Answered by AI
Has Pembrolizumab received market authorization from the FDA?
"Pembrolizumab has been given a safety score of 3 because it is a phase 3 trial, meaning that there is data supporting both its efficacy and safety."
Answered by AI
What is the extent of research on Pembrolizumab?
"City of Hope Comprehensive Cancer Center first researched pembrolizumab in 1997 and, since then, 3029 studies have completed. At this moment, 2574 studies are recruiting patients with many of them located in Québec, Quebec."
Answered by AI
Are we still enrolling patients in this experiment?
"The clinical trial in question is not currently looking for patients, as shown by the latest update on clinicaltrials.gov. Although this specific study is no longer recruiting, there are 2865 other trials that are still open to participants."
Answered by AI
What goals does this scientific research project hope to accomplish?
"The primary outcome of this clinical trial, which will be measured over a period of up to 42 months, is overall survival (OS). In addition to the primary outcome, this trial will also assess secondary outcomes including change from baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire symptom specific scale for endometrial cancer (EORTC QLQ-EN24) score, number of participants who discontinue study treatment due to an adverse event (AE), and disease-free survival (DFS) as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by combined positron emission"
Answered by AI
At how many different locations can patients participate in this clinical trial?
"In addition to CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 3002) in Québec, Mount Sinai Cancer Center ( Site 3081) in Miami Beach, and Legacy Good Samaritan Medical Center ( Site 3033) in Portland, there are 37 other medical centres running this trial."
Answered by AI
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