NCT04221945

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,060 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Placebo for pembrolizumab	IV infusion
DRUG	Cisplatin	IV infusion
RADIATION	External Beam Radiotherapy (EBRT)	Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
RADIATION	Brachytherapy	Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Timeline

• Start date: 2020-05-12
• Primary completion: 2025-01-07
• Completion: 2026-01-26
• First posted: 2020-01-09
• Last updated: 2026-02-20
• Results posted: 2026-01-05

Locations

176 sites across 30 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Japan, Norway, Peru, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study