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.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: Up to approximately 49 months
Month 25
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
Month 24
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Month 25
Time to Deterioration (TTD) 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
Time to Deterioration (TTD) 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
Month 27
Number of Participants Who Experience at Least One Adverse Event (AE)
Month 30
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)
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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)
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)
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Month 49
Overall Survival
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Pembrolizumab
17%Decreased appetite
16%Fatigue
16%Dyspnoea
16%Cough
15%Anaemia
12%Constipation
12%Hypothyroidism
11%Nausea
11%Diarrhoea
11%Rash
10%Weight decreased
10%Pruritus
10%Asthenia
10%Pyrexia
10%Alanine aminotransferase increased
10%Back pain
9%Arthralgia
9%Aspartate aminotransferase increased
8%Vomiting
8%Chest pain
7%Pneumonia
7%Headache
7%Haemoptysis
6%Hyperthyroidism
6%Upper respiratory tract infection
6%Blood alkaline phosphatase increased
6%Musculoskeletal pain
6%Hypertension
5%Oedema peripheral
5%Pain in extremity
5%Myalgia
5%Insomnia
4%Pneumonitis
4%Dizziness
3%Stomatitis
3%Malaise
2%Death
2%Pleural effusion
2%Pulmonary embolism
2%Leukopenia
1%Pericardial effusion
1%Colitis
1%Neutrophil count decreased
1%Platelet count decreased
1%White blood cell count decreased
1%Autoimmune hepatitis
1%Bronchitis
1%Sepsis
1%Interstitial lung disease
1%Pulmonary haemorrhage
1%Respiratory failure
1%Neutropenia
1%Thrombocytopenia
1%Neuropathy peripheral
1%Peripheral sensory neuropathy
Trial Design
2 Treatment Groups
Carboplatin+paclitaxel
1 of 2
Pembrolizumab
1 of 2
Active Control
Experimental Treatment
350 Total Participants · 2 Treatment Groups
Primary Treatment: pembrolizumab · No Placebo Group · Phase 3
Pembrolizumab
Biological
Experimental Group · 1 Intervention: pembrolizumab · Intervention Types: BiologicalCarboplatin+paclitaxelActiveComparator Group · 4 Interventions: docetaxel, cisplatin, carboplatin, paclitaxel · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 49 months
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,997 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,784 Patients Enrolled for Endometrial Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
28 Previous Clinical Trials
14,465 Total Patients Enrolled
2 Trials studying Endometrial Cancer
378 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,684 Previous Clinical Trials
4,957,778 Total Patients Enrolled
15 Trials studying Endometrial Cancer
2,988 Patients Enrolled for Endometrial Cancer
Gynecologic Oncology GroupNETWORK
249 Previous Clinical Trials
69,329 Total Patients Enrolled
21 Trials studying Endometrial Cancer
4,332 Patients Enrolled for Endometrial Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,639 Previous Clinical Trials
7,941,988 Total Patients Enrolled
5 Trials studying Endometrial Cancer
1,906 Patients Enrolled for Endometrial Cancer
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments