Evidence map›Paper›PMID 31980466›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase II KEYNOTE-158 Study.

Jonathan Strosberg, Nobumasa Mizuno, Toshihiko Doi, Enrique Grande, Jean-Pierre Delord, Ronnie Shapira-Frommer, Emily Bergsland, Manisha Shah, Marwan Fakih, Shunji Takahashi and 8 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02628067 (A Clinical Trial of Pembrolizumab), which is not on this map. Cited by 135 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
135citing papers in PubMed, 3 pooled it
20.7field-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.

NCT02628067 phase2active not recruitingnot on this map

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2027Enrolled1,609ConditionsAdvanced Cancer, Anal Carcinoma, Anal Cancer, Biliary CancerArmspembrolizumab
3 · Its place in the literature

Who cites it

135 citing papers in PubMed, 3 syntheses or guidelines pooled it, 217 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Cabozantinib plus Atezolizumab in Advanced, Progressive Endocrine Malignancies: A Multicohort, Basket, Phase II Trial (CABATEN/GETNE-T1914).Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  5. Trial
  6. Trial
  7. Clinical Benefit From Immunotherapy in Patients With SCLC Is Associated With Tumor Capacity for Antigen Presentation.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023
    Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Rectal neuroendocrine tumors: Update.World journal of gastrointestinal oncology · 2026
    Review
  18. Article
  19. Review
  20. Review

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

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 16 institutions in 6 countries.

Jonathan StrosbergNeuroendocrine Division, Moffitt Cancer Center, Tampa, Florida. Jonathan.Strosberg@moffitt.org.
Nobumasa MizunoDepartment of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0001-9704-1885
Toshihiko DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Enrique GrandeDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Jean-Pierre DelordDepartment of Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.ORCID 0000-0001-7305-5561
Ronnie Shapira-FrommerOncology Institute and Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Ramat-Gan, Israel.
Emily BergslandDepartment of Medicine, University of California San Francisco, San Francisco, California.
Manisha ShahDivision of Medical Oncology, Department of Internal Medicine, Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Marwan FakihMedical Oncology, City of Hope, Duarte, California.
Shunji TakahashiDepartment of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Sarina A Piha-PaulInvestigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center, Houston, Texas.
Bert O'NeilDivision of Hematology and Oncology, Indiana University Health Hospital, Indianapolis, Indiana.
Sajeve ThomasHematology and Oncology, University of Florida Health Cancer Center-Orlando, Orlando, Florida.
Martijn P LolkemaDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Menghui ChenMRL, Merck & Co., Inc., Kenilworth, New Jersey.
Nageatte IbrahimMRL, Merck & Co., Inc., Kenilworth, New Jersey.ORCID 0000-0003-0794-949X
Kevin NorwoodMRL, Merck & Co., Inc., Kenilworth, New Jersey.
Julien HadouxDepartment of Head and Neck Oncology, Gustave Roussy, Villejuif, France.ORCID 0000-0002-1276-3289
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAichi Cancer Center · JPCity Of Hope National Medical Center · USErasmus MC Cancer Institute · NLIndiana University Health · USInstitut Claudius Regaud · FRInstitut Gustave Roussy · FRMD Anderson Cancer Center Madrid · ESMoffitt Cancer Center · USNational Cancer Center Hospital East · JPOrlando Health · USSheba Medical Center · ILThe Cancer Institute Hospital · JPThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposeKEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) investigated the efficacy and safety of pembrolizumab across multiple cancers. We present results from patients with previously treated advanced well-differentiated neuroendocrine tumors (NET). PATIENTS AND

methodsPembrolizumab 200 mg was administered every 3 weeks for 2 years or until progression, intolerable toxicity, or physician/patient decision. Tumor imaging was performed every 9 weeks for the first year and then every 12 weeks. Endpoints included objective response rate (ORR) per RECIST v1.1 by independent central radiologic review (primary) and duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (secondary).

resultsA total of 107 patients with NETs of the lung, appendix, small intestine, colon, rectum, or pancreas were treated. Median age was 59.0 years (range, 29-80), 44.9% had ECOG performance status 1, 40.2% had received ≥3 prior therapies for advanced disease, and 15.9% had PD-L1-positive tumors (combined positive score ≥1). Median follow-up was 24.2 months (range, 0.6-33.4). ORR was 3.7% (95% CI, 1.0-9.3), with zero complete responses and four partial responses (three pancreatic and one rectal) all in patients with PD-L1-negative tumors. Median DOR was not reached, with one of four responses ongoing after ≥21 months follow-up. Median PFS was 4.1 months (95% CI, 3.5-5.4); the 6-month PFS rate was 39.3%. Median OS was 24.2 months (95% CI, 15.8-32.5). Treatment-related adverse events (AE) occurred in 75.7% of patients, 21.5% of whom had grade 3-5 AEs.

conclusionsPembrolizumab monotherapy showed limited antitumor activity and manageable safety in patients with previously treated advanced well-differentiated NETs.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenDisease ProgressionDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedNeuroendocrine TumorsProgrammed Cell Death 1 ReceptorSurvival RateAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID31980466
PMCPMC7811789
OpenAlexW3002637272

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.