Evidence map›Paper›PMID 30951193›Full record

Trial reportCancer2019

A phase 2, randomized trial evaluating the combination of dalantercept plus axitinib in patients with advanced clear cell renal cell carcinoma.

Martin H Voss, Rupal S Bhatt, Nicholas J Vogelzang, Mayer Fishman, Robert S Alter, Brian I Rini, J Thaddeus Beck, Monika Joshi, Ralph Hauke, Michael B Atkins and 9 more

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

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 10% 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

13 citing papers in PubMed, 25 citations in OpenAlex.

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  13. Emerging therapeutic agents for genitourinary cancers.Journal of hematology & oncology · 2019
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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

19 authors at 17 institutions in 1 country.

Martin H VossMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-0551-5807
Rupal S BhattBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Nicholas J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas, Nevada.
Mayer FishmanMoffit Cancer Center, Tampa, Florida.
Robert S AlterJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.
Brian I RiniTaussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
J Thaddeus BeckHighlands Oncology Group, Fayetteville, Arkansas.
Monika JoshiPenn State Cancer Institute, Hershey, Pennsylvania.
Ralph HaukeNebraska Methodist Hospital, Omaha, Nebraska.
Michael B AtkinsGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC.
Earle BurgessLevine Cancer Institute, Carolinas Medical Center, Charlotte, North Carolina.
Theodore F LoganIndiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana.
David ShafferNew York Oncology Hematology, Albany, New York.
Rahul ParikhUniversity of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
Nauman MoazzamRocky Mountain Cancer Centers, Aurora, Colorado.
Xiaosha ZhangAcceleron Pharma Inc, Cambridge, Massachusetts.
Chad GlasserAcceleron Pharma Inc, Cambridge, Massachusetts.
Matthew L ShermanAcceleron Pharma Inc, Cambridge, Massachusetts.
Elizabeth R PlimackFox Chase Cancer Center, Philadelphia, Pennsylvania.
Acceleron Pharma (United States) · USBeth Israel Deaconess Medical Center · USCarolinas Medical Center · USCleveland Clinic · USComprehensive Cancer Centers of Nevada · USFox Chase Cancer Center · USGeorgetown University · USHackensack University Medical Center · USHighlands Oncology Group · USHouston Methodist · USIndiana University Health · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USNew York Oncology Hematology · USPenn State Milton S. Hershey Medical Center · USRocky Mountain Cancer Centers · USUPMC Hillman Cancer Center · US

Funding

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

Abstract

backgroundIn a prior open-label study, the combination of dalantercept, a novel antiangiogenic targeting activin receptor-like kinase 1 (ALK1), plus axitinib was deemed safe and tolerable with a promising efficacy signal in patients with advanced renal cell carcinoma (RCC).

methodsIn the current phase 2, randomized, double-blind, placebo-controlled study, patients with clear cell RCC previously treated with 1 prior angiogenesis inhibitor were randomized 1:1 to receive axitinib plus dalantercept versus axitinib plus placebo. Randomization was stratified by the type of prior therapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were PFS in patients with ≥2 prior lines of anticancer therapy, overall survival, and the objective response rate.

resultsBetween June 10, 2014, and February 23, 2017, a total of 124 patients were randomly assigned to receive axitinib plus dalantercept (59 patients) or placebo (65 patients). The median PFS was not found to be significantly different between the treatment groups (median, 6.8 months vs 5.6 months; hazard ratio, 1.11 [95% CI, 0.71-1.73; P = .670]). Neither group reached the median overall survival (hazard ratio, 1.39 [95% CI, 0.70-2.77; P = .349]). The objective response rate was 19.0% (11 of 58 patients; 95% CI, 9.9%-31.4%) in the dalantercept plus axitinib group and 24.6% (15 of 61 patients; 95% CI, 14.5%-37.3%) in the placebo plus axitinib group. At least 1 treatment-emergent adverse event of ≥grade 3 was observed in 59% of patients (34 of 58 patients) in the dalantercept group and 64% of patients (39 of 61 patients) in the placebo group. One treatment-related death occurred in the placebo plus axitinib group.

conclusionsAlthough well tolerated, the addition of dalantercept to axitinib did not appear to improve treatment-related outcomes in previously treated patients with advanced RCC.

Indexed as

Activin Receptors, Type IIAdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsAxitinibCarcinoma, Renal CellDiarrheaDouble-Blind MethodFatigueFemaleHumansHypertensionImmunoglobulin Fc FragmentsKidney NeoplasmsActivin Receptors, Type IIACVRL1 protein, humanALK1-Fc fusion protein, humanAngiogenesis InhibitorsAxitinibImmunoglobulin Fc FragmentsRecombinant Fusion Proteinsangiogenesisantiangiogenic agentschemotherapydrug therapyrandomized controlled trialrenal cell carcinoma

Identifiers

PMID30951193
PMCPMC6602847
OpenAlexW2934087229

What OpenQuestion holds

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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.