Evidence map›Paper›PMID 40590325›Full record

Trial reportJournal of gynecologic oncology2025

Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis.

Yong-Man Kim, Shin Nishio, Se Ik Kim, Kosei Hasegawa, Coraline Dubot, M Valeria Cáceres, Krishnansu S Tewari, Domenica Lorusso, Jeong-Won Lee, Wen-Shiung Liou and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03635567 (A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03635567 phase3completednot on this map

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)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2024Enrolled617ConditionsCervical CancerArmsPembrolizumab, Paclitaxel, Cisplatin, Carboplatin, Bevacizumab
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Yong-Man Kim *Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, Korea. ymkim@amc.seoul.kr.ORCID 0000-0003-3225-5748
Shin Nishio *Kurume University School of Medicine, Kurume, Japan.ORCID 0000-0003-2526-630X
Se Ik KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-9790-6735
Kosei HasegawaSaitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-1903-7001
Coraline DubotInstitut Curie Saint-Cloud, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Saint-Cloud, France.ORCID 0009-0006-6550-9432
M Valeria CáceresInstituto de Oncología Ángel H. Roffo, Buenos Aires, Argentina.ORCID 0009-0006-7115-7226
Krishnansu S TewariUniversity of California, Irvine, CA, USA.ORCID 0000-0002-8417-7000
Domenica LorussoHumanitas San Pio X Hospital Milan, Humanitas University, Rozzano, Italy.ORCID 0000-0003-0981-0598
Jeong-Won LeeDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0002-6110-4909
Wen-Shiung LiouKaohsiung Veterans General Hospital, Kaohsiung, Taiwan.ORCID 0000-0003-3917-8108
Kan LiMerck & Co., Inc., Rahway, NJ, USA.ORCID 0000-0002-5762-7440
Cumhur TekinMerck & Co., Inc., Rahway, NJ, USA.ORCID 0009-0003-9579-2935
Nicoletta ColomboGynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0003-2225-715X
Bradley J MonkFlorida Cancer Specialists and Research Institute, West Palm Beach, FL, USA.ORCID 0000-0001-6985-0159

Funding

Merck & Co., Inc.
6 · The paper itself

Abstract

objectiveIn the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.

methodsParticipants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator's discretion. PFS and OS were dual primary endpoints.

resultsNinety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23-0.77); median OS was not reached and 20.4 months, respectively (HR=0.53; 95% CI=0.28-0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19-0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22-0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).

conclusionThese data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.

trial registrationClinicalTrials.gov Identifier: NCT03635567.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabNeoplasm Recurrence, LocalUterine Cervical NeoplasmsAdultAgedCarboplatinCisplatinEast Asian PeopleFemaleHumansMiddle AgedPaclitaxelProgression-Free SurvivalAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinCisplatinPaclitaxelpembrolizumabCervical CancerEast AsiaPembrolizumab

Identifiers

PMID40590325
PMCPMC12226315

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.