Evidence map›Paper›PMID 29462123›Full record

ArticleAmerican journal of clinical oncology2018

Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study.

Roger B Cohen, Jean-Pierre Delord, Toshihiko Doi, Sarina A Piha-Paul, Stephen V Liu, Jill Gilbert, Alain P Algazi, Silvia Damian, Ruey-Long Hong, Christophe Le Tourneau and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in American journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02054806 (Phase IB Study of Pembrolizumab), which is not on this map. Cited by 109 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing 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.

NCT02054806 phase1completednot on this map

Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled477ConditionsSolid TumorArmsPembrolizumab
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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  6. Axitinib plus Avelumab in Recurrent/Metastatic Adenoid Cystic Carcinoma: Biomarker Analysis and Updated Results of the Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  10. Phase II Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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49 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.

Roger B Cohen*University of Pennsylvania, Philadelphia, PA †Institut Claudius Regaud, Toulouse §§U900 INSERM Research Unit, Saint-Cloud ‡‡Institut Curie, Paris ##Gustave Roussy, Villejuif, France ‡National Cancer Center Hospital East, Chiba, Japan §The University of Texas MD Anderson Cancer Center, Houston, TX ∥Georgetown University Hospital, Washington, DC ¶Vanderbilt University School of Medicine, Nashville, TN #Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA **Fondazione IRCCS Istituto Nazionale dei Tumori Medical Oncology, Milan, Italy ††National Taiwan University Hospital, Taipei, Taiwan ∥∥Princess Margaret Cancer Centre ¶¶Ontario Institute for Cancer Research, Toronto, ON, Canada ***Vall d'Hebron Institute of Oncology, Barcelona, Spain †††Maryland Oncology Hematology PA, Rockville, MD ‡‡‡Merck & Co. Inc., Kenilworth, NJ §§§Seoul National University Hospital, Seoul, Republic of Korea.
Jean-Pierre Delord
Toshihiko Doi
Sarina A Piha-Paul
Stephen V Liu
Jill Gilbert
Alain P Algazi
Silvia Damian
Ruey-Long Hong
Christophe Le Tourneau
Daphne Day
Andrea Varga
Elena Elez
John Wallmark
Sanatan Saraf
Pradeep Thanigaimani
Jonathan Cheng
Bhumsuk Keam

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

objectivesTreatment options for patients with unresectable or metastatic salivary gland carcinoma (SGC) are limited. Safety and efficacy of pembrolizumab for SGC expressing programmed death ligand 1 (PD-L1) were explored. MATERIALS AND

methodsA cohort of patients with advanced, PD-L1-positive SGC was enrolled in the nonrandomized, multicohort, phase Ib trial of pembrolizumab in patients with PD-L1-positive advanced solid tumors (KEYNOTE-028; NCT02054806). Key inclusion criteria included recurrent or metastatic disease, failure of prior systemic therapy, and PD-L1 expression on ≥1% of tumor or stroma cells (per a prototype immunohistochemistry assay). Patients received pembrolizumab 10 mg/kg every 2 weeks for ≥2 years or until confirmed disease progression or unacceptable toxicity. Primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by investigator review.

resultsTwenty-six patients with PD-L1-positive SGC were enrolled and treated; median age was 57 years, 88% were men, and 74% had received prior therapy for recurrent/metastatic disease. Confirmed objective response rate after median follow-up of 20 months was 12% (95% confidence interval, 2%-30%), with 3 patients achieving partial response; there were no complete responses. Median duration of response was 4 months (range, 4 to 21 mo). Treatment-related adverse events occurred in 22 patients (85%), resulting in discontinuation in 2 patients and death in 1 (interstitial lung disease); those occurring in ≥15% of patients were diarrhea, decreased appetite, pruritus, and fatigue.

conclusionsPembrolizumab demonstrated promising antitumor activity and a manageable safety profile in patients with advanced, PD-L1-positive SGC.

Identifiers

PMID29462123
PMCPMC6211783

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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.