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Alkylating agents

Immunotherapy vs Chemotherapy 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
Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR
Has received no prior systemic therapy for EC except for the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 49 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.

Who is the study for?
This trial is for women with advanced or recurrent endometrial carcinoma that's mismatch repair deficient (dMMR) and who haven't had systemic chemotherapy before. They should be in good physical condition, not pregnant, willing to use contraception, and able to provide a tumor tissue sample. Those with active CNS metastases, recent major surgeries, other cancers within 3 years (except certain skin cancers), active infections requiring therapy, HIV infection or autoimmune diseases treated in the last 2 years can't join.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of pembrolizumab against standard chemotherapy (carboplatin and paclitaxel). The goal is to see if pembrolizumab improves progression-free survival and overall survival better than the chemo combination. Participants will be randomly assigned to one of these treatments.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, fatigue, skin reactions, hormonal gland problems or infusion-related reactions. Chemotherapy can lead to hair loss, nausea/vomiting, blood cell count changes increasing infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis is advanced or recurrent endometrial cancer or carcinosarcoma, confirmed to have mismatch repair deficiency.
Select...
I haven't had systemic therapy for EC, except allowed treatments.
Select...
I had radiation over 2 weeks ago, no ongoing side effects, and no steroids needed.
Select...
I stopped my hormonal therapy for endometrial cancer more than a week ago.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can provide a sample of my tumor that has not been treated with radiation for testing.
Select...
I am positive for Hepatitis B but have been on antiviral therapy for over 4 weeks with an undetectable viral load.
Select...
I had Hepatitis C but now have no detectable virus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 49 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 49 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
+6 more

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Alanine aminotransferase increased
9%
Hypothyroidism
9%
Constipation
9%
Diarrhoea
9%
Aspartate aminotransferase increased
9%
Decreased appetite
9%
Bronchitis
9%
Arthralgia
9%
Haemoptysis
9%
Nasopharyngitis
6%
Anaemia
6%
Asthenia
6%
Pruritus
6%
Blood alkaline phosphatase increased
6%
Headache
6%
Cough
6%
Pneumonia
3%
Haematemesis
3%
Lymph gland infection
3%
Pneumonia bacterial
3%
Subdural haemorrhage
3%
Tumour associated fever
3%
Rash
3%
Chest pain
3%
Malaise
3%
Leukopenia
3%
Hyperthyroidism
3%
Nausea
3%
Pyrexia
3%
Upper respiratory tract infection
3%
White blood cell count decreased
3%
Hyperglycaemia
3%
Dyspnoea
3%
Back pain
3%
Myalgia
3%
Upper gastrointestinal haemorrhage
3%
Hypertension
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PembrolizumabExperimental Treatment1 Intervention
Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years).
Group II: Carboplatin+paclitaxelActive Control4 Interventions
Participants receive a combination of paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2018
Completed Phase 3
~6240

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,382 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,784 Patients Enrolled for Endometrial Cancer
GOG FoundationNETWORK
40 Previous Clinical Trials
14,972 Total Patients Enrolled
4 Trials studying Endometrial Cancer
1,498 Patients Enrolled for Endometrial Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,359 Total Patients Enrolled
4 Trials studying Endometrial Cancer
866 Patients Enrolled for Endometrial Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05173987 — Phase 3
Endometrial Cancer Research Study Groups: Carboplatin+paclitaxel, Pembrolizumab
Endometrial Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05173987 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05173987 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Centre Hospitalier de l'Université de Montréal ( Site 0519)
What portion of applicants met pre-screening criteria?
Met criteria
~148 spots leftby Jul 2026