CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,060 enrolled
Drug / intervention
Pembrolizumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04221945
NCT04221945Phase 3Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Jan 9, 2020·Updated Feb 20, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Placebo for pembrolizumab, and 3 other interventions for Uterine Cervical Neoplasms. Completed, enrolled 1,060 participants across 176 sites in 30 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cervical Neoplasms
CountriesAustralia, 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, United States
CollaboratorsGOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 9, 2020
Enrollment StartMay 12, 2020
Primary CompletionJan 7, 2025
Study CompletionJan 26, 2026
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.5 years ago

Interventions

Pembrolizumabbiological

IV infusion

Placebo for pembrolizumabdrug

IV infusion

Cisplatindrug

IV infusion

External Beam Radiotherapy (EBRT)radiation

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Brachytherapyradiation

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed