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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3 year recurrence-free survival

Secondary outcome measures

5 year recurrence free survival

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

Incidence of adverse events

+3 more

Other outcome measures

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 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 2

~1730

Brachytherapy

2007

Completed Phase 3

~2100

Computed Tomography

2017

Completed Phase 2

~2720

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,499 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,684 Total Patients Enrolled

Floor BackesPrincipal InvestigatorNRG Oncology

Media Library

Brachytherapy Clinical Trial Eligibility Overview. Trial Name: NCT04214067 — Phase 3

Endometrial Adenocarcinoma Research Study Groups: Arm I (EBRT, brachytherapy), Arm II (EBRT, brachytherapy, pembrolizumab)

Endometrial Adenocarcinoma Clinical Trial 2023: Brachytherapy Highlights & Side Effects. Trial Name: NCT04214067 — Phase 3

Brachytherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04214067 — Phase 3

Frequently Asked Questions

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

Is this clinical trial limited to a few clinics in Canada?

"There are a total of 100 hospitals enrolling patients for this study, some notable locations include Memorial Sloan Kettering Cancer Center in New york, University of Rochester in Rochester, and Ascension Saint Vincent Indianapolis Hospital in Indianapolis."

Answered by AI

Has the Food and Drug Administration cleared Pembrolizumab for public consumption?

"Pembrolizumab is considered safe based on our team's 3-point scale."

Answered by AI

Are people with the condition being sought for this research project?

"No, this study has concluded recruitment for participants. The original posting was on February 7th, 2020 and the last update was on September 16th, 2020. For other stage ii uterine corpus cancer ajcc v8 studies, there are 328 active trials. In addition, there are 1000 studies for Pembrolizumab currently admitting participants."

Answered by AI

What are the primary treatments that Pembrolizumab is used for?

"Pembrolizumab is a medication used to treat malignant neoplasms. It is also approved to treat microsatellite instability high and unresectable melanoma if the patient has already undergone chemotherapy."

Answered by AI

Could you please give us a summary of Pembrolizumab's previous clinical trials?

"There are presently 1000 Pembrolizumab trials underway, with 122 of them in Phase 3. While the majority of these studies are taking place in Houston, Texas, there are 35962 total locations running Pembrolizumab trials."

Answered by AI