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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: IV infusion
Carboplatin: IV infusion
Paclitaxel: IV infusion
Placebo for pembrolizumab: IV infusion
Docetaxel: IV infusion docetaxel 75 mg/m\^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.
Cisplatin: Cisplatin 75 mg/m\^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.
External Beam Radiotherapy (EBRT): ≥4500 cGY given according to local practice, at the discretion of the investigator
Cisplatin (as radiosensitizer): If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m\^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29
Brachytherapy: Given according to local practice, at the discretion of the investigator
Study summary
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
Primary outcome measure(s)
- Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence — Up to approximately 42 months
DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented. - Overall Survival (OS) — Up to approximately 54 months
OS is defined as the time from randomization to death due to any cause.
Trial sites (231)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Abington Hospital - Asplundh Cancer Center ( Site 3073) | Willow Grove | Pennsylvania | |
| Sanford Gynecology Oncology ( Site 3045) | Sioux Falls | South Dakota | |
| UT Southwestern Medical Center ( Site 3063) | Dallas | Texas | |
| VCU Massey Cancer Center ( Site 3068) | Richmond | Virginia | |
| Centro de Oncología e Investigación de Buenos Aires ( Site 1005) | Berazategui | Buenos Aires | |
| IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006) | CABA | Buenos Aires | |
| CEMIC ( Site 1009) | CABA | Buenos Aires | |
| Hospital Britanico de Buenos Aires ( Site 1002) | Ciudad Autónoma de Buenos Aires | Buenos Aires | |
| Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003) | Mar del Plata | Buenos Aires | |
| Instituto de Oncologia de Rosario ( Site 1004) | Rosario | Santa Fe Province | |
| IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010) | Buenos Aires | Argentina | |
| Hospital Aleman ( Site 1001) | Buenos Aires | Argentina | |
| Centro Oncologico Riojano Integral ( Site 1007) | La Rioja | Argentina | |
| Medizinische Universitat Graz ( Site 2004) | Graz | Styria | |
| Medizinische Universitaet Innsbruck ( Site 2001) | Innsbruck | Tyrol |
+ 191 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04634877 on ClinicalTrials.gov ↗ ← All trials in France