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Pembrolizumab + Radiation for Endometrial Cancer

Phase 3

Waitlist Available

Led By Floor Backes

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by immunohistochemistry (IHC) and/or evidence of microsatellite instability (MSI) high

Patients must have received no prior therapy for endometrial cancer

Must not have

Patients with active autoimmune disease or history of autoimmune disease that might recur and affect vital organ function

Uncontrolled intercurrent illness including ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether adding immunotherapy to radiation treatment can reduce the risk of cancer recurrence better than radiation alone for endometrial cancer patients.

Who is the study for?

This trial is for patients with newly diagnosed stage I-II endometrioid endometrial cancer. They must have had specific imaging, surgery, and show no signs of disease outside the uterus. Eligible participants should not have received prior therapy for their cancer, meet certain health criteria, and be within a set time after initial surgery.

What is being tested?

The study is testing if adding pembrolizumab (an immunotherapy drug) to usual radiation therapy reduces the risk of cancer recurrence better than radiation alone in early-stage high intermediate risk endometrial cancer.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in organs, infusion reactions, fatigue, skin rash or itching. Radiation can lead to localized skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows signs of high microsatellite instability or lacks certain proteins.

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I have not received any treatment for endometrial cancer.

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I have had surgery to determine the stage of my cancer.

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I have Stage I endometrial cancer and meet the age and risk criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that could come back and harm my organs.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have had pneumonitis that needed steroids or have it now.

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I have been treated with specific antibodies or similar drugs before.

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I have not taken any medications that are not allowed in the study.

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I do not have significant liver disease, such as active hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

3 year recurrence-free survival

Secondary study objectives

5 year recurrence free survival

Impact of circulating tumor deoxyribonucleic acid (ctDNA) on treatment outcomes

Incidence of adverse events

+3 more

Other study objectives

Biomarker analysis

Functional Assessment of Cancer Therapy (FACT)-Immune Checkpoint Modulator (ICM) subscale

Potential transformations of the severity of adverse events

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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: Arm II (EBRT, brachytherapy, pembrolizumab)Experimental Treatment9 Interventions

Patients undergo EBRT and brachytherapy as in Arm I. Within 7 days prior to the start of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 6 weeks for up to 1 year (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT scans, MRI scans, or x-ray imaging throughout the trial.

Group II: Arm I (EBRT, brachytherapy)Active Control8 Interventions

Patients undergo pelvic EBRT daily for 5-6 weeks and vaginal brachytherapy completed within 7 days after completion of EBRT in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT scans, MRI scans, or x-ray imaging throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Brachytherapy

2007

Completed Phase 3

~2140