Evidence map›Paper›PMID 31774688›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study.

Emmanuel S Antonarakis, Josep M Piulats, Marine Gross-Goupil, Jeffrey Goh, Kristiina Ojamaa, Christopher J Hoimes, Ulka Vaishampayan, Ranaan Berger, Ahmet Sezer, Tuomo Alanko and 14 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02787005 (Phase II Trial of Pembrolizumab), which is not on this map. Cited by 463 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
463citing papers in PubMed, 5 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.

NCT02787005 phase2completednot on this map

Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-199)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2022Enrolled388ConditionsMetastatic Castration-resistant Prostate CancerArmsPembrolizumab
3 · Its place in the literature

Who cites it

463 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  17. Evaluating Immune Checkpoint Blockade in Metastatic Castration-Resistant Prostate Cancers with Deleterious CDK12 Alterations in the Phase 2 IMPACT Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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403 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Emmanuel S AntonarakisJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Josep M PiulatsCatalan Cancer Institute, Bellvitge Biomedical Research Institute, Centro de Investigación Biomédica en Red de Cáncer, Hospitalet de Llobregat, Barcelona, Spain.
Marine Gross-GoupilInstitut Bergonié, Bordeaux, France.
Jeffrey GohRoyal Brisbane and Women's Hospital, Herston, QLD, Australia.
Kristiina OjamaaEast Tallinn Central Hospital, Tallinn, Estonia.
Christopher J HoimesCase Comprehensive Cancer Center at University Hospitals Seidman Cancer Center, Cleveland, OH.
Ulka VaishampayanKarmanos Cancer Institute, Wayne State University, Detroit, MI.
Ranaan BergerChaim Sheba Medical Center, Tel Hashomer, Israel.
Ahmet SezerBaşkent University Hospital Adana, Adana, Turkey.
Tuomo AlankoDocrates Cancer Center, Helsinki, Finland.
Ronald de WitErasmus MC Cancer Institute, Rotterdam, the Netherlands.
Chunde LiKarolinska Institutet, Stockholm, Sweden.
Aurelius OmlinCantonal Hospital St Gallen, University of Bern, Bern, Switzerland.
Giuseppe ProcopioFondazione Istituto Nazionale Tumori, Milan, Italy.
Satoshi FukasawaChiba Cancer Center, Chiba, Japan.
Ken-Ichi TabataKitasato University, Kanagawa, Japan.
Se Hoon ParkSungkyunkwan University, Samsung Medical Center, Seoul, South Korea.
Susan FeyerabendStudienpraxis Urologie, Nürtingen, Germany.
Charles G DrakeNew York Presbyterian/Columbia University Medical Center, New York, NY.
Haiyan WuMSD China, Beijing, China.
Ping QiuMerck & Co, Kenilworth, NJ.
Jeri KimMerck & Co, Kenilworth, NJ.
Christian PoehleinMerck & Co, Kenilworth, NJ.
Johann Sebastian de BonoThe Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Julie Lynn Boerner · 1985 to 2026
$68.4M
6 · The paper itself

Abstract

purposePembrolizumab has previously shown antitumor activity against programmed death ligand 1 (PD-L1)-positive metastatic castration-resistant prostate cancer (mCRPC). Here, we assessed the antitumor activity and safety of pembrolizumab in three parallel cohorts of a larger mCRPC population.

methodsThe phase II KEYNOTE-199 study included three cohorts of patients with mCRPC treated with docetaxel and one or more targeted endocrine therapies. Cohorts 1 and 2 enrolled patients with RECIST-measurable PD-L1-positive and PD-L1-negative disease, respectively. Cohort 3 enrolled patients with bone-predominant disease, regardless of PD-L1 expression. All patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary end point was objective response rate per RECIST v1.1 assessed by central review in cohorts 1 and 2. Secondary end points included disease control rate, duration of response, overall survival (OS), and safety.

resultsTwo hundred fifty-eight patients were enrolled: 133 in cohort 1, 66 in cohort 2, and 59 in cohort 3. Objective response rate was 5% (95% CI, 2% to 11%) in cohort 1 and 3% (95% CI, < 1% to 11%) in cohort 2. Median duration of response was not reached (range, 1.9 to ≥ 21.8 months) and 10.6 months (range, 4.4 to 16.8 months), respectively. Disease control rate was 10% in cohort 1, 9% in cohort 2, and 22% in cohort 3. Median OS was 9.5 months in cohort 1, 7.9 months in cohort 2, and 14.1 months in cohort 3. Treatment-related adverse events occurred in 60% of patients, were of grade 3 to 5 severity in 15%, and led to discontinuation of treatment in 5%.

conclusionPembrolizumab monotherapy shows antitumor activity with an acceptable safety profile in a subset of patients with RECIST-measurable and bone-predominant mCRPC previously treated with docetaxel and targeted endocrine therapy. Observed responses seem to be durable, and OS estimates are encouraging.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCohort StudiesHumansInfusions, IntravenousMaleMiddle AgedProstatic Neoplasms, Castration-ResistantAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanpembrolizumab

Identifiers

PMID31774688
PMCPMC7186583

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.