Evidence map›Paper›PMID 34301810›Full record

Trial reportJournal for immunotherapy of cancer2021

First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study.

Sandra P D'Angelo, Celeste Lebbé, Laurent Mortier, Andrew S Brohl, Nicola Fazio, Jean-Jacques Grob, Natalie Prinzi, Glenn J Hanna, Jessica C Hassel, Felix Kiecker and 5 more

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 4 pooled it
8.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 4 syntheses or guidelines pooled it, 139 citations in OpenAlex.

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  17. Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026
    Review
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15 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

15 authors at 11 institutions in 4 countries.

Sandra P D'AngeloMemorial Sloan Kettering Cancer Center, New York, New York, USA dangelos@mskcc.org.ORCID 0000-0002-3736-3783
Celeste LebbéAP-HP Dermatology and CIC, INSERM U976, Saint Louis Hospital, Université de Paris, Paris, France.
Laurent MortierDermatology Clinic, CARADERM and University of Lille, INSERM U1189, Lille Hospital-Claude Huriez Hospital, Lille Cedex, France.
Andrew S BrohlSarcoma Department and Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Nicola FazioEuropean Institute of Oncology, IEO, IRCCS, Milan, Italy.
Jean-Jacques GrobAP-HM Hospital, Aix-Marseille University, Marseille, France.
Natalie PrinziMedical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Glenn J HannaHead and Neck Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Jessica C HasselDepartment of Dermatology and National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.
Felix KieckerCharité Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.
Sara GeorgesEMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA; an affiliate of Merck KGaA, Darmstadt, Germany.
Barbara Ellers-LenzGlobal Biostatistics, Merck KGaA, Darmstadt, Germany.
Parantu ShahEMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA; an affiliate of Merck KGaA, Darmstadt, Germany.
Gülseren GüzelClinical Development, Merck KGaA, Darmstadt, Germany.
Paul NghiemDivision of Dermatology, University of Washington Medical Center at South Lake Union, Seattle, Washington, USA.ORCID 0000-0003-2784-963X
Merck (Germany) · DEInserm · FRAix-Marseille Université · FRCharité - Universitätsmedizin Berlin · DEDana-Farber Cancer Institute · USFondazione IRCCS Istituto Nazionale dei Tumori · ITHeidelberg University · DEIstituti di Ricovero e Cura a Carattere Scientifico · ITMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USUniversity of Washington Medical Center · 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
NCI NIH HHS P01 CA225517NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundAvelumab (anti-programmed death ligand 1 (PD-L1)) is approved in multiple countries for the treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. We report efficacy and safety data and exploratory biomarker analyses from a cohort of patients with mMCC treated with first-line avelumab in a phase II trial.

methodsPatients with treatment-naive mMCC received avelumab 10 mg/kg intravenously every 2 weeks. The primary endpoint was durable response, defined as objective response (complete or partial response; assessed by independent review) lasting ≥6 months. Additional assessments included progression-free survival (PFS), overall survival (OS), safety, and biomarker analyses.

resultsIn 116 patients treated with avelumab, median follow-up was 21.2 months (range: 14.9-36.6). Thirty-five patients had a response lasting ≥6 months, giving a durable response rate of 30.2% (95% CI: 22.0% to 39.4%). The objective response rate was 39.7% (95% CI: 30.7% to 49.2%). Median PFS was 4.1 months (95% CI: 1.4 to 6.1) and median OS was 20.3 months (95% CI: 12.4 to not estimable). Response rates were numerically higher in patients with PD-L1+ tumors, Merkel cell polyomavirus (MCPyV)-negative tumors, and tumors with increased intratumoral CD8

conclusionIn patients with mMCC, first-line treatment with avelumab led to responses in 40% and durable responses in 30%, and was associated with a low rate of grade 3/4 treatment-related adverse events.

Indexed as

AgedAntibodies, Monoclonal, HumanizedBiomarkers, TumorCarcinoma, Merkel CellCohort StudiesHumansImmunotherapyNeoplasm MetastasisAntibodies, Monoclonal, HumanizedavelumabBiomarkers, Tumorclinical trialsgene expression profilingimmunotherapyphase II as topicskin neoplasmstumor biomarkers

Identifiers

PMID34301810
PMCPMC8311489
OpenAlexW3184314094

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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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.