A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination with Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent. (GOG-3053)

Purpose

The treatment of participants with newly diagnosed, high-risk EC following surgery with curative intent.

Criteria

Criteria:

1.      Have a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma and

·         Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy.

·         Is at high risk for recurrence following treatment with curative intent surgery.

2.      Must be disease free.

3.      Have not received any radiation or systemic therapy, including immunotherapy or hormonal therapy, in any setting including the neoadjuvant setting for EC.

4.      Have adequate organ function.

You Cannot

1.       Have recurrent endometrial carcinoma or carcinosarcoma.

2.       Have residual tumor.

3.       Have history of a second malignancy.

4.       Have an active auto-immune disease.

5.       Have a history of pneumonitis.

6.       Have HIV or Hepatitis B or C

7.       Have had an organ transplant.

Details

1.      Standard of care chemotherapy with study drug or placebo every 3 weeks for 6 cycles then every 6 weeks for 6 cycles.

2.      Labs drawn with standard of care visits.

3.      Cat scan every 24 weeks.

4.      Study stipend

Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: Western
IRB Number:
Trial Type: Device
Sponsor: Merck