KEYNOTE-A18: NCT04221945: Phase 3: Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer
- CTD
- Dec 15, 2024
- 2 min read
First Posted | 2020-01-09 |
Trial status | Active, not recruiting |
Sponsor | Merck Sharp & Dohme LLC |
Abstract Presentation | Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer: Final analysis results of the phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study.
Meeting Abstract: 2025 ASCO Annual Meeting II June 04, 2025 LBA38 Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: A randomized, double-blind, phase III ENGOT-cx11/GOG-3047/KEYNOTE-A18 study
ESMO Congress 2023, 20 - 24 October 2023 |
Peer-reviewed journal publication | Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial Lancet - 2024 Apr 6 Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial Lancet - 2024 Oct 5 |
FDA | FDA Approved. FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer January 12, 2024 |
Press Release | Merck’s KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy Significantly Improved Progression-Free Survival (PFS) Versus Concurrent Chemoradiotherapy Alone in Newly Diagnosed, High-Risk Locally Advanced Cervical Cancer October 20, 2023 Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer March 15, 2024 |
NCCN |
KEYNOTE-A18: NCT04221945: Phase 3: Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer
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)
Official 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/GOG-3047) |
Intervention / Treatment: |
Biological: Pembrolizumab Drug: Placebo for pembrolizumab Drug: Cisplatin Radiation: External Beam Radiotherapy (EBRT) Radiation: Brachytherapy |
Other Study ID Numbers: |
3475-A18 MK-3475-A18 ( Other Identifier ) (OTHER: MSD) KEYNOTE-A18 ( Other Identifier ) (OTHER: MSD) ENGOT-cx11 ( Other Identifier ) (OTHER: European Network for Gynaecological Oncological Trial groups) 205189 ( Registry Identifier ) (REGISTRY: JAPAC-CTI) GOG-3047 ( Other Identifier ) (OTHER: Gynecologic Oncology Group Foundation) 2022-501972-25-00 ( Registry Identifier ) (REGISTRY: EU CT) U1111-1282-6395 ( Registry Identifier ) (REGISTRY: UTN) 2019-003152-37 ( EudraCT Number ) |
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT04221945 |