Evidence map›Paper›PMID 27648727›Full record

Trial reportCancer2016

A phase 2 study of dalantercept, an activin receptor-like kinase-1 ligand trap, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Antonio Jimeno, Marshall R Posner, Lori J Wirth, Nabil F Saba, Roger B Cohen, Elizabeta C Popa, Athanassios Argiris, Kenneth F Grossmann, Ammar Sukari, Dawn Wilson and 7 more

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

Trial report in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  7. BMP9 regulates the endothelial secretome to drive pulmonary hypertension.bioRxiv : the preprint server for biology · 2025
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  12. An emerging class of new therapeutics targeting TGF, Activin, and BMP ligands in pulmonary arterial hypertension.Developmental dynamics : an official publication of the American Association of Anatomists · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 11 institutions in 1 country.

Antonio JimenoDepartments of Medicine and Otolaryngology, University of Colorado Cancer Center and Gates Center for Regenerative Medicine, Aurora, Colorado.
Marshall R PosnerDepartments of Medicine and Otolaryngology, Icahn School of Medicine at Mount Sinai, New York, New York.
Lori J WirthDepartment of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Nabil F SabaDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Roger B CohenDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Elizabeta C PopaDepartment of Medicine, Joan and Sanford I Weill Cornell Medical College of Cornell University, New York, New York.
Athanassios ArgirisDepartment of Medicine, Institute of Drug Development, University of Texas Health Science Center at San Antonio, San Antonio, Texas.
Kenneth F GrossmannDepartment of Internal Medicine, Huntsman Cancer Institute, Salt Lake City, Utah.
Ammar SukariKarmanos Cancer Center, Wayne State University, Detroit, Michigan.
Dawn WilsonAcceleron Pharma, Cambridge, Massachusetts.
Xiaosha ZhangAcceleron Pharma, Cambridge, Massachusetts.
Jade SunAcceleron Pharma, Cambridge, Massachusetts.
Chad GlasserAcceleron Pharma, Cambridge, Massachusetts.
Kenneth M AttieAcceleron Pharma, Cambridge, Massachusetts.
Matthew L ShermanAcceleron Pharma, Cambridge, Massachusetts.
Susan S PandyaAcceleron Pharma, Cambridge, Massachusetts.
Jared WeissDepartment of Hematology and Oncology, University of North Carolina, Chapel Hill, North Carolina.
Acceleron Pharma (United States) · USCornell University · USHuntsman Cancer Institute · USIcahn School of Medicine at Mount Sinai · USMassachusetts General Hospital · USPiedmont Cancer Institute · USThe University of Texas Health Science Center at San Antonio · USUniversity of Colorado Cancer Center · USUniversity of North Carolina Hospitals · USUniversity of Pennsylvania · USWayne State University · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

backgroundPatients with platinum-refractory, recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN) have limited options. Activin receptor-like kinase 1 (ALK1) is a type I receptor of the transforming growth factor β superfamily expressed on activated endothelial cells. Dalantercept is an ALK1 receptor fusion protein that acts as a ligand trap to block signaling through ALK1 and inhibits stages of angiogenesis involved in blood vessel maturation and stabilization. In a phase 1 study, dalantercept demonstrated clinical activity in patients with RM-SCCHN. The objective of the current study was to evaluate the activity of dalantercept in RM-SCCHN.

methodsForty-six patients received dalantercept at doses of 80 mg (n = 2), 0.6 mg/kg (n = 13), or 1.2 mg/kg (n = 31) subcutaneously every 3 weeks. The primary endpoint was the overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Secondary endpoints included progression-free survival and overall survival, safety and tolerability, and pharmacokinetic and pharmacodynamic assessments.

resultsForty patients were evaluable for response (13 who received dalantercept 0.6 mg/kg and 27 who received dalantercept 1.2 mg/kg). The overall response rate was 5% (n = 2), and 35% of patients had stable disease; 44% of patients who received 1.2 mg/kg and 30.8% of those who received 0.6 mg/kg achieved disease control (partial response or stable disease). The median progression-fee survival was 1.4 months (95% confidence interval, 1.3-2.2 months), and the median overall survival was 7.1 months (95% confidence interval, 5.5-11.1 months). Drug-related adverse events (>15%) were anemia, fatigue, peripheral edema, headache, and hyponatremia.

conclusionsIn an unselected, heavily pretreated population of patients with RM-SCCHN, dalantercept monotherapy resulted in a favorable safety profile but only modest dose-dependent activity, and it did not meet the primary efficacy objective of the study. Cancer 2016;122:3641-9. © 2016 American Cancer Society.

Indexed as

Activin Receptors, Type IIAgedAngiogenesis InhibitorsAntineoplastic AgentsCarcinoma, Squamous CellDisease-Free SurvivalFemaleHead and Neck NeoplasmsHumansImmunoglobulin Fc FragmentsLigandsMaleMiddle AgedNeoplasm Recurrence, LocalNeovascularization, PathologicRecombinant Fusion ProteinsActivin Receptors, Type IIACVRL1 protein, humanALK1-Fc fusion protein, humanAngiogenesis InhibitorsAntineoplastic AgentsImmunoglobulin Fc FragmentsLigandsRecombinant Fusion Proteinsactivin receptor-like kinase 1 (ALK1)angiogenesisbone morphogenetic protein 9 (BMP9)dalantercept. squamous cell carcinoma of the head and neck (SCCHN)

Identifiers

PMID27648727
PMCPMC6901028
OpenAlexW2522160622

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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.