KEYNOTE - 826: NCT03635567: Phase 3: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy First line Cervical cancer
- CTD
- Dec 15, 2021
- 2 min read
Updated: Jan 31
First Posted | 2018-08-17 |
Trial status | Completed |
Sponsor | Merck Sharp & Dohme LLC |
Abstract Presentation | KEYNOTE-826: Final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer. June 3, 2023
2023 ASCO Annual Meeting
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Peer-reviewed journal publication | Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer September 18, 2021 - N Engl J Med First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826 J Clin Oncol- 2023 Dec 20 |
FDA | FDA approves pembrolizumab combination for the first-line treatment of cervical cancer October 13,2021 |
Press Release | Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Patients With Persistent, Recurrent or Metastatic Cervical Cancer June 22, 2021 |
NCCN |
KEYNOTE - 826: NCT03635567: Phase 3: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy First line Cervical cancer
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer
(MK-3475-826/KEYNOTE-826)
Official Title: |
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826) |
Intervention / Treatment: |
Biological: Pembrolizumab Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Biological: Bevacizumab Drug: Placebo to pembrolizumab |
Other Study ID Numbers: |
3475-826 MK-3475-826 ( Other Identifier ) (OTHER: MSD) KEYNOTE-826 ( Other Identifier ) (OTHER: MSD) 184183 ( Registry Identifier ) (REGISTRY: JAPAC-CTI) 2018-001440-53 ( EudraCT Number ) |
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT03635567 |