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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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
Must not have
Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 59 months
Awards & highlights

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
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My cancer is a type of advanced or recurrent endometrial carcinoma or carcinosarcoma confirmed to be dMMR.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I had Hepatitis C but now have no detectable virus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a uterine sarcoma, but not adenosarcoma or neuroendocrine tumor.
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I have had treatment for advanced or metastatic endometrial cancer.
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My endometrial cancer has normal mismatch repair function.
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I have active brain metastases or carcinomatous meningitis.
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I am currently being treated for an infection.
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I have been treated for an autoimmune disease in the last 2 years.
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I have received an organ or tissue transplant from another person.
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I have been treated with specific drugs that help my immune system fight cancer.
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I am eligible for surgery or radiotherapy aimed at curing my condition.
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I have been diagnosed with HIV.
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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 59 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 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%
Bronchitis
9%
Diarrhoea
9%
Hypothyroidism
9%
Decreased appetite
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Nasopharyngitis
9%
Aspartate aminotransferase increased
9%
Alanine aminotransferase increased
6%
Asthenia
6%
Cough
6%
Headache
6%
Anaemia
6%
Pruritus
6%
Pneumonia
6%
Blood alkaline phosphatase increased
3%
Lymph gland infection
3%
Hyperthyroidism
3%
Dyspnoea
3%
Malaise
3%
Pneumonia bacterial
3%
Upper gastrointestinal haemorrhage
3%
Upper respiratory tract infection
3%
Rash
3%
Hypertension
3%
Pyrexia
3%
Subdural haemorrhage
3%
White blood cell count decreased
3%
Back pain
3%
Chest pain
3%
Haematemesis
3%
Myalgia
3%
Hyperglycaemia
3%
Tumour associated fever
3%
Nausea
3%
Leukopenia
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC 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
2017
Completed Phase 3
~5750

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
45 Previous Clinical Trials
17,154 Total Patients Enrolled
6 Trials studying Endometrial Cancer
1,881 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,732 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,784 Patients Enrolled for Endometrial Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
37 Previous Clinical Trials
17,269 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
~147 spots leftby May 2027
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