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NRG-GY020

Trial

Clinical Trial Title

Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

Trial Status

Open to Enrollment

Start Date

April 16, 2020

Location

Trial Type

Cancer - Adult Oncology

Specific Condition

Endometrial Cancer

Description

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.

Eligibility Criteria

Eligibility Criteria

  • Submission of tumor tissue is required for all patients. Investigators should check with their site Pathology Department regarding release of tissue biospecimens before approaching patients about participation in the trial.
  • Patients must have:
  • A. Stage I endometrioid endometrial cancer and a combination of age and risk factors as listed below:
  •  Age >70 and ≥1 risk factor
  •  Age 50-70 and 2 risks factors
  •  Age <50 and 3 risk factors
  •  Risk factors:
  •  Myometrial invasion ≥ 50%
  •  Lymphovascular space invasion
  • Grade 2 or 3
  • OR
  • B. Stage II endometrioid endometrial cancer
  • Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by IHC and/or evidence of MSI high.
  • Patients must have undergone surgical staging with at least hysterectomy, removal of cervix, bilateral (if both are present) salpingo-oophorectomy, and either sentinel lymph node assessment or complete pelvic +/- aortic lymphadenectomy.
  • Patients must have received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy.
  • ECOG Performance Status of 0, 1 or 2

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Monday, May 18, 2020 02:02:49 PM