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)
Conditions
Cervix
Phase III
Volunteers
Health Professionals
What is the purpose of this trial?
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.
- Trial withMerck Sharp & Dohme
- Start Date12/03/2020
- End Date02/07/2024
I'm interested in volunteering
If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343
Principal Investigator
Sub-Investigators
- Andrea Brennan
- David Witt, MD
- Elena Ratner, MD
- Gary Altwerger, MD
- Gulden Menderes, MD
- Harold Tara Jr, MD
- Justin Harold, MD
- Justin Persico, MD
- Kathleen Fenn, MD
- Lisa Baker
- Martha Luther
- Masoud Azodi, MD
- Melissa Young, MD, PhD
- Michael Cohenuram, MD
- Neal Fischbach, MD
- Peter Schwartz, MD
- Shari Damast, MD
- Stephanie Cerrito
- Vaagn Andikyan, MD
- Yi An, MD
- Last Updated07/15/2021
- Study HIC#2000028332