Pembrolizumab + Radiation for Endometrial Cancer

Recruiting at302 trial locations

Overseen by Floor Backes

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

Research Team

Floor Backes

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

You need to have had a specific type of imaging that shows no signs of disease outside of the uterus.

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

I registered for the trial soon after my initial surgery.

Exclusion Criteria

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

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

I am currently in a clinical trial for endometrial cancer or was in one within the last 4 weeks.

Treatment Details

Interventions

• Brachytherapy (Radiation)
• External Beam Radiation Therapy (Radiation)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm II (EBRT, brachytherapy, pembrolizumab) Experimental Treatment 9 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 Control 8 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.

Brachytherapy is already approved in Canada for the following indications:

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School