Evidence map›Paper›PMID 31046082›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study.

U A Matulonis, R Shapira-Frommer, A D Santin, A S Lisyanskaya, S Pignata, I Vergote, F Raspagliesi, G S Sonke, M Birrer, D M Provencher and 11 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02674061 (A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer), which is not on this map. Cited by 525 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
525citing papers in PubMed, 3 pooled it
39.0field-weighted citation impact, top 1% of its field
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.

NCT02674061 phase2completednot on this map

A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2021Enrolled376ConditionsOvarian NeoplasmsArmsPembrolizumab
3 · Its place in the literature

Who cites it

525 citing papers in PubMed, 3 syntheses or guidelines pooled it, 800 citations in OpenAlex.

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465 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 10 countries.

U A MatulonisDivision of Gynecologic Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: Ursula_Matulonis@dfci.harvard.edu.
R Shapira-FrommerOncology Institute and Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat Gan, Israel.
A D SantinObstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, New Haven, USA.
A S LisyanskayaDepartment of Gynaecological Oncology, City Clinical Oncology Dispensary, Saint Petersburg, Russia.
S PignataDepartment of Urogynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G Pascale", IRCCS, Naples, Italy.
I VergoteDepartment of Obstetrics and Gynaecology and Gynaecologic Oncology, University Hospital Leuven, Leuven, Belgium.
F RaspagliesiFondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
G S SonkeDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
M BirrerComprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, USA.
D M ProvencherHôpital Notre-Dame - Pavillon L-C Simard, Centre Hospitalier de L'Université de Montréal (CHUM), Montreal, Canada.
J SehouliGynecology and Obstetrics, Charité-Medical University of Berlin, Berlin, Germany.
N ColomboDepartment of Surgical Sciences, University of Milano-Bicocca and European Institute of Oncology, Milano, Italy.
A González-MartínMedical Oncology, Clinica Universidad de Navarra; formerly of MD Anderson International España, Madrid.
A OakninVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
P B OttevangerMedical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
V RudaitisClinic of Obstetrics and Gynecology, Vilnius University Institute of Clinical Medicine, Vilnius, Lithuania.
K KatcharCompanion Diagnostics, Merck & Co., Inc, Kenilworth, USA.
H WuBARDS, MSD China, Beijing, China.
S KeefeClinical Development, Merck & Co., Inc., Kenilworth, USA.
J RumanClinical Development, Merck & Co., Inc., Kenilworth, USA.
J A LedermannUCL Cancer Institute and UCL Hospitals, Department of Oncology, University College London, London, UK.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCharité - Universitätsmedizin Berlin · DECity Clinical Oncology Center · RUClinica Universidad de Navarra · ESDana-Farber Cancer Institute · USEuropean Institute of Oncology · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITHôpital Notre-Dame · CAIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITRadboud University Nijmegen · NLSheba Medical Center · ILThe Netherlands Cancer Institute · NLUniversity College London · GBUniversity of Alabama at Birmingham · USVall d'Hebron Hospital Universitari · ESVilnius University · LTYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced recurrent ovarian cancer (ROC) is the leading cause of gynecologic cancer-related death in developed countries and new treatments are needed. Previous studies of immune checkpoint blockade showed low objective response rates (ORR) in ROC with no identified predictive biomarker. PATIENTS AND

methodsThis phase II study of pembrolizumab (NCT02674061) examined two patient cohorts with ROC: cohort A received one to three prior lines of treatment with a platinum-free interval (PFI) or treatment-free interval (TFI) between 3 and 12 months and cohort B received four to six prior lines with a PFI/TFI of ≥3 months. Pembrolizumab 200 mg was administered intravenously every 3 weeks until cancer progression, toxicity, or completion of 2 years. Primary end points were ORR by Response Evaluation Criteria in Solid Tumors version 1.1 per blinded independent central review by cohort and by PD-L1 expression measured as combined positive score (CPS). Secondary end points included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

resultsCohort A enrolled 285 patients; the first 100 served as the training set for PD-L1 biomarker analysis. Cohort B enrolled 91 patients. ORR was 7.4% for cohort A and 9.9% for cohort B. Median DOR was 8.2 months for cohort A and not reached for cohort B. DCR was 37.2% and 37.4%, respectively, in cohorts A and B. Based on the training set analysis, CPS 1 and 10 were selected for evaluation in the confirmation set. In the confirmation set, ORR was 4.1% for CPS <1, 5.7% CPS ≥1, and 10.0% for CPS ≥10. PFS was 2.1 months for both cohorts. Median OS was not reached for cohort A and was 17.6 months for cohort B. Toxicities were consistent with other single-agent pembrolizumab trials.

conclusionsSingle-agent pembrolizumab showed modest activity in patients with ROC. Higher PD-L1 expression was correlated with higher response. CLINICAL TRIAL NUMBER: Clinicaltrials.gov, NCT02674061.

Indexed as

Adenocarcinoma, Clear CellAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCohort StudiesCystadenocarcinoma, SerousFemaleFollow-Up StudiesHumansNeoplasm Recurrence, LocalOvarian NeoplasmsPrognosisSurvival RateAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabcombined positive scoreimmunotherapyovarian cancerpembrolizumab

Identifiers

PMID31046082
OpenAlexW2890261294

What OpenQuestion holds

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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.