Evidence map›Paper›PMID 29127533›Full record

Trial reportInvestigational new drugs2018

A phase 2 study of ontuxizumab, a monoclonal antibody targeting endosialin, in metastatic melanoma.

Sandra P D'Angelo, Omid A Hamid, Ahmad Tarhini, Dirk Schadendorf, Bartosz Chmielowski, Frances A Collichio, Anna C Pavlick, Karl D Lewis, Susan C Weil, John Heyburn and 3 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  15. Preclinical Evaluation and Dosimetry of [Molecular imaging and biology · 2020
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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

13 authors at 10 institutions in 2 countries.

Sandra P D'AngeloMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Omid A HamidThe Angeles Clinic and Research Institute, Los Angeles, CA, USA.
Ahmad TarhiniUniversity of Pittsburgh, Pittsburgh, PA, USA.
Dirk SchadendorfUniversitätsklinikum Essen, Essen, Germany.
Bartosz ChmielowskiUniversity of California, Los Angeles, CA, USA.
Frances A CollichioUniversity of North Carolina, Chapel Hill, NC, USA.
Anna C PavlickNew York University, Lake Success, NY, USA.
Karl D LewisUniversity of Colorado Cancer Center, Aurora, CO, USA.
Susan C WeilMorphotek, Inc., Exton, PA, USA.
John HeyburnMorphotek, Inc., Exton, PA, USA.
Charles SchweizerMorphotek, Inc., Exton, PA, USA.
Daniel J O'ShannessyMorphotek, Inc., Exton, PA, USA.
Richard D CarvajalColumbia University Medical Center, 177 Ft Washington Avenue, New York, NY, 10032, USA. rdc2150@cumc.columbia.edu.
Morphotek (United States) · USAngeles Clinic and Research Institute · USColumbia University Irving Medical Center · USEssen University Hospital · DEMemorial Sloan Kettering Cancer Center · USNew York University · USUniversity of California, Los Angeles · USUniversity of Colorado Cancer Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Objectives Ontuxizumab (MORAB-004) is a first-in-class monoclonal antibody that interferes with endosialin function, which is important in tumor stromal cell function, angiogenesis, and tumor growth. This Phase 2 study evaluated the 24-week progression-free survival (PFS) value, pharmacokinetics, and tolerability of 2 doses of ontuxizumab in patients with metastatic melanoma. Patients and methods Patients with metastatic melanoma and disease progression after receiving at least 1 prior systemic treatment were randomized to receive ontuxizumab (2 or 4 mg/kg) weekly, without dose change, until disease progression. Results Seventy-six patients received at least 1 dose of ontuxizumab (40 received 2 mg/kg, 36 received 4 mg/kg). The primary endpoint, 24-week PFS value, was 11.4% (95% Confidence Interval [CI]: 5.3%-19.9%) for all patients (13.5% for 2 mg/kg and 8.9% for 4 mg/kg). The median PFS for all patients was 8.3 weeks (95% CI: 8.1-12.3 weeks). One patient receiving 4 mg/kg had a partial response, as measured by Response Evaluation Criteria in Solid Tumors v1.1. Twenty-seven of 66 response evaluable patients (40.9%) had stable disease. The median overall survival was 31.0 weeks (95% CI: 28.3-44.0 weeks). The most common adverse events overall were headache (55.3%), fatigue (48.7%), chills (42.1%), and nausea (36.8%), mostly grade 1 or 2. Conclusions Ontuxizumab at both doses was well tolerated. The 24-week PFS value was 11.4% among all ontuxizumab-treated patients. The overall response rate was 3.1% at the 4 mg/kg dose, with clinical benefit achieved in 42.4% of response evaluable patients. Efficacy of single-agent ontuxizumab at these doses in melanoma was low.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntigens, CDAntigens, NeoplasmAntineoplastic AgentsFemaleHumansKaplan-Meier EstimateMaleMelanomaMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntigens, CDAntigens, NeoplasmAntineoplastic AgentsCD248 protein, humanontuxizumabAngiogenesisEndosialinMetastatic melanomaMORAB-004OntuxizumabTEM-1Tumor endothelial marker-1

Identifiers

PMID29127533
PMCPMC9175266
OpenAlexW2767826944

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.