Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

Conditions

• Endometrial Endometrioid Adenocarcinoma
• Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
• Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Brachytherapy — RADIATION
  Undergo vaginal brachytherapy
• Computed Tomography — PROCEDURE
  Undergo CT
• External Beam Radiation Therapy — RADIATION
  Undergo EBRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pembrolizumab — BIOLOGICAL
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• X-Ray Imaging — PROCEDURE
  Undergo x-rays

Study Details

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.

Key Dates

Start date

Apr 9, 2020

Status verified

Feb 2026

Primary completion

Dec 30, 2025

Completion

Feb 5, 2027

Study Design

Enrollment

164 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (EBRT, brachytherapy)
  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.
• Experimental: Arm II (EBRT, brachytherapy, pembrolizumab)
  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.

Primary Outcome Measure

3 year recurrence-free survival [ Time Frame: Time from study entry (randomization) to the time of withdrawal, death, or cancer recurrence, assessed at 3 years ]

Locations (275)

Related coverage on Hipa.ai

• Pembrolizumab Trial for Endometrial Cancer Reaches Primary Completion
  Pembrolizumab · Dec 30, 2025 · ClinicalTrials.gov

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