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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

Pivotal Trial

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 59 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

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

2017

Completed Phase 3

~5890

0 / 14Eligibility criteria met