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) (NCT04634877)
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 (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama - Birmingham ( Site 3061) — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (231 Sites)
Showing the first 25 of 231 sites.
- University of Alabama - Birmingham ( Site 3061) — Birmingham, Alabama
- University of South Alabama, Mitchell Cancer Institute ( Site 3058) — Mobile, Alabama
- HonorHealth Research Institute - Biltmore ( Site 3043) — Phoenix, Arizona
- Arizona Oncology Associates PC- HOPE ( Site 3049) — Tucson, Arizona
- UCSD Moores Cancer Center ( Site 3053) — La Jolla, California
- University Of Colorado ( Site 3051) — Aurora, Colorado
- Smilow Cancer Hospital at Yale New Haven ( Site 3070) — New Haven, Connecticut
- Mount Sinai Cancer Center ( Site 3081) — Miami Beach, Florida
- Northside Hospital ( Site 3036) — Atlanta, Georgia
- Northwestern Memorial Hospital ( Site 3044) — Chicago, Illinois
- Parkview Cancer Institute ( Site 3067) — Fort Wayne, Indiana
- Indiana University Melvin and Bren Simon Cancer Center ( Site 3071) — Indianapolis, Indiana
- University of Iowa Hospital and Clinics ( Site 3046) — Iowa City, Iowa
- Norton Cancer Institute - St. Matthews ( Site 3056) — Louisville, Kentucky
- WK Physicians Network/Gynecologic Oncology Associates ( Site 3047) — Shreveport, Louisiana
- University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 3037) — Worcester, Massachusetts
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076) — Mineola, New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042) — New York, New York
- Montefiore Medical Center ( Site 3065) — The Bronx, New York
- Duke Cancer Center ( Site 3072) — Durham, North Carolina
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080) — Fargo, North Dakota
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3066) — Columbus, Ohio
- Legacy Good Samaritan Medical Center ( Site 3033) — Portland, Oregon
- Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078) — Philadelphia, Pennsylvania
- AHN West Penn Hospital ( Site 3060) — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Endometrial Neoplasms
- Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer — Tucson, Arizona
- A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor — Little Rock, Arkansas
- Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) — Phoenix, Arizona
Explore by condition: All Endometrial Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.