Evidence map›Paper›PMID 31586757›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2019

Phase II trial of the glycoprotein non-metastatic B-targeted antibody-drug conjugate, glembatumumab vedotin (CDX-011), in recurrent osteosarcoma AOST1521: A report from the Children's Oncology Group.

Lisa M Kopp, Suman Malempati, Mark Krailo, Yun Gao, Allen Buxton, Brenda J Weigel, Thomas Hawthorne, Elizabeth Crowley, Jeffrey A Moscow, Joel M Reid and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02487979 (A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate, CDX-011), which is not on this map. Cited by 57 papers.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed
5.4field-weighted citation impact, top 3% 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.

NCT02487979 phase2completednot on this map

A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate, CDX-011 (Glembatumumab Vedotin, CR011-vcMMAE; NSC# 763737), in Recurrent or Refractory Osteosarcoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2016 to 2021Enrolled22ConditionsRecurrent OsteosarcomaArmsGlembatumumab Vedotin, Laboratory Biomarker Analysis, Pharmacological Study
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 76 citations in OpenAlex.

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  10. Tumor-expressed GPNMB orchestrates Siglec-9Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
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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

14 authors at 12 institutions in 1 country.

Lisa M KoppDepartment of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA; University of Arizona Cancer Center, University of Arizona, Tucson, AZ, USA. Electronic address: lkopp@email.arizona.edu.
Suman MalempatiDepartment of Pediatrics, Oregon Health & Sciences University, Portland, OR, USA.
Mark KrailoChildren's Oncology Group, Monrovia, CA, USA; Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Yun GaoChildren's Oncology Group, Monrovia, CA, USA.
Allen BuxtonChildren's Oncology Group, Monrovia, CA, USA.
Brenda J WeigelDepartment of Pediatrics, University of Minnesota Medical Center, Minneapolis, MN, USA.
Thomas HawthorneCelldex Therapeutics, USA.
Elizabeth CrowleyCelldex Therapeutics, USA.
Jeffrey A MoscowNational Cancer Institute, Bethesda, MD, USA.
Joel M ReidDivision of Oncology Research, Department of Oncology, Mayo Clinic, Rochester, MN, USA.
Victor VillalobosDivision of Medical Oncology, UC Denver, Denver, CO, USA.
R Lor RandallDepartment of Orthopedics, UC Davis, Davis, CA, USA.
Richard GorlickDivision of Pediatrics, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
Katherine A JanewayPediatric Hematology-Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA, USA.
Celldex Therapeutics (United States) · USChildren's Oncology Group · USDana-Farber/Boston Children's Cancer and Blood Disorders Center · USDenver Health Medical Center · USMayo Clinic in Arizona · USNational Cancer Institute · USOregon Health & Science University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Arizona · USUniversity of California, Davis · USUniversity of Minnesota Medical Center · USUniversity of Southern California · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA233324
6 · The paper itself

Abstract

backgroundThe prognosis is poor for children and adolescents with recurrent osteosarcoma (OS). Glycoprotein non-metastatic B (gpNMB) is a glycoprotein highly expressed in OS cells. We conducted a phase II study of glembatumumab vedotin (GV), a fully human IgG2 monoclonal antibody (CR011) against gpNMB conjugated to the microtubule inhibitor, monomethyl auristatin E. PATIENTS AND

methodsPatients aged ≥12 years and <50 years with relapsed or refractory OS were eligible. GV 1.9 mg/kg/dose was administered on day 1 of each 21 day cycle. Pharmacokinetics were mandatory in patients aged <15 years. gpNMB expression was measured by immunohistochemistry. The primary end-point was disease control at 4 months and Response Evaluation Criteria in Solid Tumours response. A 2-stage design was used to determine efficacy.

resultsTwenty-two patients were enrolled, and all were evaluable for response. Antibody-drug conjugate levels were detectable in patients, although small numbers limit comparison to adult data. The toxicities observed were similar to the previous studies with GV. The most common grade III adverse event was rash. One death from end organ failure occurred possibly related to GV. Of the 22 patients, one patient had a partial response, and two had stable disease. There was no correlation between gpNMB expression and response to GV.

conclusionsGV was well tolerated in this population. Although there was some antitumour activity, the extent of disease control in stage I did not meet the level required to proceed to stage II. TRIAL REGISTRATION NUMBERS: NCT02487979.

Indexed as

AdolescentAdultAge of OnsetAntibodies, MonoclonalBone NeoplasmsChildFemaleHumansImmunoconjugatesMaleNeoplasm Recurrence, LocalOsteosarcomaPrognosisTreatment OutcomeYoung AdultAntibodies, Monoclonalglembatumumab vedotinImmunoconjugatesAdolescentClinical trialMolecular targeted therapyOsteosarcomaPaediatricsYoung adult

Identifiers

PMID31586757
PMCPMC6952063
OpenAlexW2978260261

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.