A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy with or without immunotherapy for the Treatment of Stages IB2-IIB, III and IVA Cervical Cancer

UVA Tracking #
Principal Investigator
Linda R Duska
Sheena Clift
Contact Phone
Official Trial Title
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)
Study Description

The UVA Cancer Center seeks women ages 18 and over who have high-risk locally advanced cervical cancer (LACC) for a clinical trial. This includes participants who have Stage IB2-IIB disease or more advanced stages of locally advanced cervical cancer, ie. Stage III and Stage IVA.

The purpose of this study is to evaluate the combined treatment of the investigational immunotherapy study drug (pembrolizumab) with concurrent chemoradiotherapy compared to placebo (inactive drug) plus concurrent chemoradiotherapy in participants with LACC. Disease response and the good and bad effects of the 2 different treatments will be studied as part of this clinical trial. The participants will not be able to choose or know which combination of treatment they will be receiving.

Treatment will be over 2 years, followed by a longer term follow-up that will include blood tests/imaging scans every 12 weeks in the first 2 years, then check-ups every 24 weeks in the 3rd year and checkups every 52 weeks in year 4 (or until your cancer worsens or you choose to start a new treatment).*
*If your cancer worsens or you need to start a new treatment for another reason, you will continue to be followed by the study team and be contacted about every 12 weeks for a health check.

If eligible and you choose to participate, research-specific tests and the study drug, pembrolizumab, will be provided at no cost to you. You or your insurance company are responsible for the cost of standard medical care including the cost of the chemoradiotherapy.

Additional information can be found here: NCT04221945