GOG-3053 B21-00

Clinical Trial Title 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
Trial Status Open to Enrollment
Start Date 04/30/2021
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Endometrial Cancer
Description The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Eligibility Criteria

Inclusion Criteria

  • Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor)
  • Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy. Pelvic lymph node sampling, para-aortic lymph node sampling
  • Has not received any radiation or systemic therapy, including immunotherapy or hormonal therapy, in any setting including the neoadjuvant setting for EC.
  • Is female and at least 18 years of age
  • Has ECOG performance status of 0 or 1

Exclusion Criteria

  • Has recurrent endometrial carcinoma or carcinosarcoma.
  • Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
  • Has residual tumor whether measurable or non-measurable after surgery.
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.

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

IRB Number Central IRB
Notes Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) - Full Text View - ClinicalTrials.gov
Principal Investigator Colleen McCormick, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org