Evidence map›Paper›PMID 30348224›Full record

ArticleJournal for immunotherapy of cancer2018

Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial.

Christophe Le Tourneau, Christopher Hoimes, Corrine Zarwan, Deborah J Wong, Sebastian Bauer, Rainer Claus, Martin Wermke, Subramanian Hariharan, Anja von Heydebreck, Vijay Kasturi and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2018. 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 104 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 6 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.

NCT01772004 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2013 to 2019Enrolled1,756ConditionsSolid TumorsArmsAvelumab
NCT07085572 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

TypeinterventionalSponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRan2025 to 2028Enrolled31ConditionsAdrenal Cortical CarcinomaArmsCemiplimab
3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  5. Evaluation of the potential for QTc prolongation with avelumab.Cancer chemotherapy and pharmacology · 2019
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  7. 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
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  16. PD-1 Blockade in Advanced Adrenocortical Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
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44 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

12 authors.

Christophe Le TourneauDepartment of Medical Oncology, Institut Curie, 26, rue d'ulm, 75005, Paris & Saint-Cloud, France. christophe.letourneau@curie.fr.
Christopher HoimesCase Western Reserve University and University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
Corrine ZarwanLahey Hospital and Medical Center, Burlington, MA, USA.
Deborah J WongUCLA Department of Medicine, California, Los Angeles, USA.
Sebastian BauerDepartment of Medical Oncology, West German Cancer Centre, University of Duisburg-Essen, Hufelandstraße, Essen, Germany.
Rainer ClausDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Martin WermkeEarly Clinical Trial Unit, University Cancer Center, Dresden, Germany.
Subramanian HariharanPfizer, Inc, New York, NY, USA.
Anja von HeydebreckMerck KGaA, Darmstadt, Germany.
Vijay KasturiEMD Serono Inc, Rockland, MA, USA.
Vikram ChandEMD Serono Research and Development Institute, Billerica, MA, USA.
James L GulleyNational Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
6 · The paper itself

Abstract

backgroundWe assessed the efficacy and safety of avelumab, an anti-programmed death ligand 1 (PD-L1) antibody, in patients with previously treated metastatic adrenocortical carcinoma (mACC).

methodsIn this phase 1b expansion cohort, patients with mACC and prior platinum-based therapy received avelumab at 10 mg/kg intravenously every 2 weeks. Continuation of mitotane was permitted; however, mitotane levels during the study were not recorded. Tumor response was assessed by Response Evaluation Criteria In Solid Tumors v1.1.

resultsFifty patients received avelumab and were followed for a median of 16.5 months. Prior treatment included ≥2 lines in 74.0%; mitotane was continued in 50.0%. The objective response rate (ORR) was 6.0% (95% CI, 1.3% to 16.5%; partial response in 3 patients). Twenty-one patients (42.0%) had stable disease as best response (disease control rate, 48.0%). Median progression-free survival was 2.6 months (95% CI, 1.4 to 4.0), median overall survival (OS) was 10.6 months (95% CI, 7.4 to 15.0), and the 1-year OS rate was 43.4% (95% CI, 27.9% to 57.9%). In evaluable patients with PD-L1+ (n = 12) or PD-L1- (n = 30) tumors (≥5% tumor cell cutoff), ORR was 16.7% vs 3.3% (P = .192). Treatment-related adverse events (TRAEs) occurred in 82.0%; the most common were nausea (20.0%), fatigue (18.0%), hypothyroidism (14.0%), and pyrexia (14.0%). Grade 3 TRAEs occurred in 16.0%; no grade 4 to 5 TRAEs occurred. Twelve patients (24.0%) had an immune-related TRAE of any grade, which were grade 3 in 2 patients (4.0%): adrenal insufficiency (n = 1), and pneumonitis (n = 1).

conclusionsAvelumab showed clinical activity and a manageable safety profile in patients with platinum-treated mACC.

trial registrationClinicaltrials.gov NCT01772004 ; registered January 21, 2013.

Indexed as

Adrenocortical CarcinomaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedNeoplasm MetastasisAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabAdrenocortical carcinomaAvelumabJAVELIN solid tumorNeuroendocrine tumorsPD-L1Phase 1

Identifiers

PMID30348224
PMCPMC6198369

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.