Evidence map›Paper›PMID 27328856›Full record

Trial reportClinical genitourinary cancer2017

A Phase II Clinical Trial of TRC105 (Anti-Endoglin Antibody) in Adults With Advanced/Metastatic Urothelial Carcinoma.

Andrea B Apolo, Fatima H Karzai, Jane B Trepel, Sylvia Alarcon, Sunmin Lee, Min-Jung Lee, Yusuke Tomita, Liang Cao, Yunkai Yu, Maria J Merino and 10 more

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

Trial report in Clinical genitourinary cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01328574 (A Phase II Study of TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
6.6field-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.

NCT01328574 phase2completednot on this map

A Phase II Study of TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2014Enrolled13ConditionsUrothelial Carcinoma, Ureteral Neoplasms, Ureter Cancer, Neoplasm, UreteralArmsTRC105
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 52 citations in OpenAlex.

  1. Trial
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  5. Review
  6. High-precision tumor resection down to few-cell level guided by NIR-IIb molecular fluorescence imaging.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  7. Article
  8. Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  9. Article
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  11. Endoglin in the Spotlight to Treat Cancer.International journal of molecular sciences · 2021
    Review
  12. Article
  13. Article
  14. Review
  15. Endoglin Targeting: Lessons Learned and Questions That Remain.International journal of molecular sciences · 2020
    Review
  16. Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Article
  17. 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

20 authors at 5 institutions in 1 country.

Andrea B ApoloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD. Electronic address: andrea.apolo@nih.gov.
Fatima H KarzaiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Jane B TrepelDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Sylvia AlarconDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Sunmin LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Min-Jung LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Yusuke TomitaDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Liang CaoGenetics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Yunkai YuGenetics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Maria J MerinoLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Ravi A MadanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Howard L ParnesGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Beatriz Walter RodriguezLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Ben K SeonRoswell Park Cancer Institute, Buffalo, NY.
James L GulleyGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Philip M ArlenGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Nancy A DawsonMedstar Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC.
William D FiggGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
William L DahutGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Center for Cancer Research · USNational Cancer Institute · USNational Institutes of Health · USGeorgetown University · USRoswell Park Comprehensive Cancer Center · US

Funding

Bladder Cancer ProgramZIABC011351 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2010 to 2025
$9.4M
NIMHD DIR TransitionZIAMD000005 · NIMHD · NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES · PI NAPOLES, ANNA MARIA · 2016 to 2018
$7.1M
Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

backgroundIn this trial we assessed the efficacy and tolerability of TRC105, a chimeric monoclonal antibody that targets CD105 (endoglin) in patients with advanced, previously treated urothelial carcinoma (UC). PATIENTS AND

methodsPatients received TRC105 15 mg/kg every 2 weeks on days 1 and 15 of each 28-day cycle. The primary end point was progression-free survival (PFS) at 6 months. Secondary end points included safety, toxicity, and overall survival (OS). CD105 expression was evaluated using immunohistochemistry (IHC) in a separate cohort of 50 UC patients. Biomarker studies included immune subsets, circulating tumor cells (CTCs), circulating endothelial cells (CECs), circulating endothelial progenitor cells (CEPs), and osteopontin.

resultsOf 13 patients enrolled, 12 were evaluable for OS and PFS. The 3-month PFS probability was 18.2% (median PFS, 1.9 months [95% confidence interval (CI), 1.8-2.1 months). This met the criterion for ending accrual on the basis of the 2-stage design. Median OS was 8.3 months (95% CI, 3.3-17.0 months). IHC for CD105 scores was not associated with T stage (P = .26) or presence of lymph nodes (P = .64). Baseline levels of regulatory T and B cells, CEPs, and changes in CEC level after TRC105 exhibited trends toward an association with PFS or OS. CTCs pre- and post-TRC105 were detected in 4 of 4 patients.

conclusionAlthough TRC105 was well tolerated, it did not improve 6-month PFS in heavily pretreated patients with advanced UC. CD105 staining was present in 50% of UC tumors at different intensities. Our observations on the pharmacodynamic significance of immune subsets, CECs, and CTCs warrant further study.

Indexed as

AgedAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Transitional CellDisease-Free SurvivalEndoglinFemaleHumansMaleMiddle AgedNeoplasm MetastasisNeoplastic Cells, CirculatingOsteopontinSurvival AnalysisTreatment OutcomeUrologic NeoplasmsAntibodies, MonoclonalAntineoplastic AgentscarotuximabEndoglinENG protein, humanOsteopontinSPP1 protein, humanAdvanced urothelial cancerAntiangiogenic therapyCD105Immune subsetsMetastatic urothelial cancerUrothelial cancer

Identifiers

PMID27328856
PMCPMC6583922
OpenAlexW2407034767

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.