Evidence map›Paper›PMID 32472503›Full record

Trial reportThe patient2020

Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial.

Jérémy Lambert, Alexia Marrel, Sandra P D'Angelo, Melissa A Burgess, Bartosz Chmielowski, Nicola Fazio, Thilo Gambichler, Jean-Jacques Grob, Céleste Lebbé, Caroline Robert and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The patient, 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 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 27% 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
NCT06039033 not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Merkel Cell Carcinoma Clinical Trials: What Are Prevailing Patient Experiences in Merkel Cell Carcinoma Studies

TypeobservationalSponsorPower Life Sciences Inc.Ran2024 to 2026Enrolled500ConditionsMerkel Cell Carcinoma
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Patient Voices in Rheumatic Immune-related Adverse Events.Rheumatic diseases clinics of North America · 2024
    Review
  5. Article
  6. Article
  7. Review
  8. Article
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

13 authors at 11 institutions in 4 countries.

Jérémy LambertPatient-Centred Outcomes, ICON Plc, Lyon, France.
Alexia MarrelPatient-Centred Outcomes, ICON Plc, Lyon, France.
Sandra P D'AngeloUniversity of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.
Melissa A BurgessMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Bartosz ChmielowskiUCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Nicola FazioDivision of Gastrointestinal Medical Oncology and Neuroendocrine Tumours, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
Thilo GambichlerSkin Cancer Center, Department of Dermatology, Ruhr University, Bochum, Germany.
Jean-Jacques GrobDepartment of Dermatology, Aix-Marseille University, Marseille, France.
Céleste LebbéUniversité de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France.
Caroline RobertDepartment of Dermatology, Institut Gustave Roussy, Villejuif, France.
Jeffrey RussellImmunocore, LLC, Conshohocken, PA, USA.
Gülseren GüzelMerck KGaA, Darmstadt, Germany.
Murtuza BharmalEMD Serono, One Technology Place, Rockland, MA, 02370, USA. murtuza.bharmal@emdserono.com.
Aix-Marseille Université · FRAssistance Publique – Hôpitaux de Paris · FREuropean Institute of Oncology · ITImmunocore (United States) · USInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USMerck (Germany) · DEOno Pharmaceutical (United States) · USRuhr University Bochum · DEUCLA Jonsson Comprehensive Cancer CenterUniversity of Pittsburgh Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Robert Damoiseaux · 1985 to 2026
$134.5M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

BACKGROUND AND

objectiveAvelumab is approved for the treatment of metastatic Merkel cell carcinoma, a rare aggressive skin cancer with a poor prognosis. The aim of this qualitative study embedded in a clinical trial was to explore patient experiences while receiving avelumab.

methodsAll treatment-naïve patients with metastatic Merkel cell carcinoma entering part B of the phase II, open-label, international, JAVELIN Merkel 200 trial (NCT02155647) were invited to participate in optional semi-structured phone interviews before avelumab administration (baseline) and at weeks 13 and 25. Interviews were conducted by trained professionals, audio-recorded, transcribed and analysed. Key concepts identified at baseline were assessed during follow-up interviews.

resultsTwenty-nine patients completed the baseline interview; 19 had at least one follow-up interview. Baseline interviews described the patients' challenging journeys before being correctly diagnosed with Merkel cell carcinoma, the negative psychological burden of living with a symptomless disease and the hope for avelumab to be a successful therapy. During the trial, most patients reported an increased or continued sense of hope and willingness to fight metastatic Merkel cell carcinoma. Patients who self-reported disease improvement (n = 12) also reported stability or improvement in physical well-being and ability to do daily activities, having more energy, worrying less and being optimistic. Six patients who reported their condition as stable (n = 4) or worsened (n = 3) reported a worsening of physical well-being. Nine patients reported fatigue/tiredness on the day of and after receiving avelumab. Baseline and longitudinal experiences were similar across countries.

conclusionsThis study suggests that patients experience perceptible benefits in physical and psychological well-being following treatment success with first-line avelumab in metastatic Merkel cell carcinoma.

Indexed as

Activities of Daily LivingAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Merkel CellFemaleHealth StatusHumansInterviews as TopicLongitudinal StudiesMaleMiddle AgedNeoplasm GradingQuality of LifeSkin NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalavelumab

Identifiers

PMID32472503
PMCPMC7340640
OpenAlexW3028627276

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.