Evidence map›Paper›PMID 32414862›Full record

Trial reportJournal for immunotherapy of cancer2020

Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial.

Sandra P D'Angelo, Shailender Bhatia, Andrew S Brohl, Omid Hamid, Janice M Mehnert, Patrick Terheyden, Kent C Shih, Isaac Brownell, Celeste Lebbé, Karl D Lewis and 8 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 103 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 6 pooled it
12.5field-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.

NCT02155647 phase2completednot on this map

A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2014 to 2023Enrolled204ConditionsCarcinoma, Merkel CellArmsAvelumab
NCT05594290 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

Window-of-opportunity Study of Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery: the MERCURY Trial

TypeinterventionalSponsorGruppo Oncologico del Nord-OvestRan2022 to 2026Enrolled36ConditionsMerkel Cell CarcinomaArmsRetifanlimab, Cisplatin, Etoposide
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 6 syntheses or guidelines pooled it, 194 citations in OpenAlex.

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  20. Neoadjuvant therapy in skin cancer: current evidence and future perspectives.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026
    Review

43 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 14 institutions in 4 countries.

Sandra P D'AngeloDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA dangelos@mskcc.org.ORCID 0000-0002-3736-3783
Shailender BhatiaDepartment of Medicine, University of Washington Medical Center, Seattle, Washington, USA.ORCID 0000-0002-3816-2238
Andrew S BrohlSarcoma Department and Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Omid HamidDepartment of Medical Oncology, The Angeles Clinic and Research Institute, Los Angeles, California, USA.
Janice M MehnertDivision of Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.
Patrick TerheydenDepartment of Dermatology, University of Lübeck, Lübeck, Germany.
Kent C ShihDepartment of Medical Oncology, Sarah Cannon Research Institute, Nashville, Tennessee, USA.
Isaac BrownellDermatology Branch, NIH, Bethesda, Maryland, USA.ORCID 0000-0002-0090-9914
Celeste LebbéDermatologie, Université de Paris, INSERM U976, Paris, France.
Karl D LewisDepartment of Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
Gerald P LinetteCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Michele MilellaDepartment of Medical Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Sara GeorgesClinical Biomarkers and Companion Diagnostics, Department of Translational Medicine, EMD Serono Research & Development Institute, Billerica, Massachusetts, USA.
Parantu ShahBioinformatics, Department of Translational Medicine, EMD Serono Research & Development Institute, Billerica, Massachusetts, USA.
Barbara Ellers-LenzGlobal Biostatistics, Merck KGaA, Darmstadt, Germany.
Marcis BajarsClinical Development, EMD Serono Research & Development Institute, Billerica, Massachusetts, USA.
Gülseren GüzelClinical Development, Merck KGaA, Darmstadt, Germany.
Paul T NghiemDivision of Dermatology, Department of Medicine, University of Washington Medical Center at South Lake Union, Seattle, Washington, USA.
Ono Pharmaceutical (United States) · USMerck (Germany) · DEUniversity of Washington Medical Center · USAngeles Clinic and Research Institute · USInserm · FRIstituti di Ricovero e Cura a Carattere Scientifico · ITMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USNational Institutes of Health · USRutgers, The State University of New Jersey · USSarah Cannon · USUniversity of Colorado Denver · USUniversity of Lübeck · DEUniversity of Pennsylvania · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Understand & overcome resistance to PD-1P01CA225517 · NCI · UNIVERSITY OF WASHINGTON · PI PAUL NGHIEM · 2019 to 2026
$22.7M
Ipilimumab for treatment of advanced Merkel cell carcinomaZIABC011450 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BROWNELL, ISAAC · 2012 to 2021
$1.0M
NCI NIH HHS P01 CA225517NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundMerkel cell carcinoma (MCC) is a rare, aggressive skin cancer associated with a high risk of metastasis. In 2017, avelumab (anti-programmed death-ligand 1 (PD-L1)) became the first approved treatment for patients with metastatic MCC (mMCC), based on the occurrence of durable responses in a subset of patients. Here, we report long-term efficacy and safety data and exploratory biomarker analyses in patients with mMCC treated with avelumab.

methodsIn a cohort of this single-arm, phase 2 trial (JAVELIN Merkel 200), patients with mMCC and disease progression after prior chemotherapy received avelumab 10 mg/kg intravenously every 2 weeks. The primary endpoint was confirmed objective response rate (ORR) by independent review per Response Evaluation Criteria in Solid Tumors V.1.1. Other assessments included duration of response, progression-free survival, overall survival (OS), safety and biomarker analyses.

resultsAs of 14 September 2018, 88 patients had been followed up for a median of 40.8 months (range 36.4-49.7 months). The ORR was 33.0% (95% CI 23.3% to 43.8%), including a complete response in 11.4% (10 patients), and the median duration of response was 40.5 months (95% CI 18.0 months to not estimable). As of 2 May 2019 (≥44 months of follow-up), the median OS was 12.6 months (95% CI 7.5 to 17.1 months) and the 42-month OS rate was 31% (95% CI 22% to 41%). Of long-term survivors (OS >36 months) evaluable for PD-L1 expression status (n=22), 81.8% had PD-L1+ tumors. In exploratory biomarker analyses, high tumor mutational burden (≥2 non-synonymous somatic variants per megabase) and high major histocompatibility complex class I expression (30% of tumors with highest expression) were associated with trends for improved ORR and OS. In long-term safety assessments (≥36 months of follow-up), no new or unexpected adverse events were reported, and no treatment-related deaths occurred.

conclusionsAvelumab showed continued durable responses and meaningful long-term survival outcomes in patients with mMCC, reinforcing avelumab as a standard-of-care treatment option for this disease. TRIAL REGISTRATION NUMBER: NCT02155647.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkers, TumorCarcinoma, Merkel CellDisease ProgressionFemaleFollow-Up StudiesHistocompatibility Antigens Class IHumansImmune Checkpoint InhibitorsMaleMiddle AgedMutationProgression-Free SurvivalAntibodies, Monoclonal, HumanizedavelumabB7-H1 AntigenBiomarkers, TumorCD274 protein, humanHistocompatibility Antigens Class IImmune Checkpoint Inhibitorsbiomarkers, tumorclinical trials, phase II as topicimmunotherapyskin neoplasms

Identifiers

PMID32414862
PMCPMC7239697
OpenAlexW3024881937

What OpenQuestion holds

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LicenceCC BY
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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.