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)

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.

Conditions

• Endometrial Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Placebo for pembrolizumab

IV infusion

DRUG

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.

DRUG

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.

RADIATION

External Beam Radiotherapy (EBRT)

≥4500 cGY given according to local practice, at the discretion of the investigator

DRUG

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

RADIATION

Brachytherapy

Given according to local practice, at the discretion of the investigator

Sponsors & Collaborators

• European Network for Gynaecological Oncological Trial Groups

  collaborator UNKNOWN

• Gynecologic Oncology Group

  collaborator NETWORK

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-10

Primary Completion

2026-09-15

Completion

2026-09-15

FDA Drug

Yes

Countries

• United States
• Argentina
• Austria
• Belgium
• Canada
• Chile
• China
• Colombia
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Israel
• Italy
• Japan
• Mexico
• Norway
• Poland
• Russia
• South Korea
• Spain
• Sweden
• Taiwan
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations