Evidence map›Paper›PMID 36717286›Full record

ArticleEuropean urology2023

A Phase 1 Trial of Durvalumab in Combination with Bacillus Calmette-Guerin (BCG) or External Beam Radiation Therapy in Patients with BCG-unresponsive Non-muscle-Invasive Bladder Cancer: The Hoosier Cancer Research Network GU16-243 ADAPT-BLADDER Study.

Noah M Hahn, Michael A O'Donnell, Jason A Efstathiou, Marianna Zahurak, Gary L Rosner, Jeff Smith, Max R Kates, Trinity J Bivalacqua, Phuoc T Tran, Daniel Y Song and 31 more

Open access · greenAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in European urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
15.6field-weighted citation impact, top 1% 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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  5. [Advances in intravesical therapy for nonZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

41 authors at 14 institutions in 1 country.

Noah M HahnJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA. Electronic address: nhahn4@jhmi.edu.
Michael A O'DonnellUniversity of Iowa Carver College of Medicine, Iowa City, IA, USA.
Jason A EfstathiouMassachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Marianna ZahurakJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Gary L RosnerJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Jeff SmithHoosier Cancer Research Network, Indianapolis, IN, USA.
Max R KatesJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Trinity J BivalacquaJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA; Division of Urology and Urologic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Phuoc T TranJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA; Department of Radiation Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, USA.
Daniel Y SongJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA; Department of Radiation Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Alex S BarasJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA; Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Andres MatosoJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA; Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Woonyoung ChoiJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Kellie N SmithJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; Johns Hopkins Bloomberg Kimmel Institute for Cancer Immunotherapy, Baltimore, MD, USA.
Drew M PardollJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; Johns Hopkins Bloomberg Kimmel Institute for Cancer Immunotherapy, Baltimore, MD, USA.
Luigi MarchionniJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Center for Computational Genomics, Baltimore, MD, USA; Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, NY, USA.
Bridget McGuireJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Mary Grace PhelanJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Burles A JohnsonJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Tanya O'NealJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
David J McConkeyJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; The Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA; The James Buchanan Brady Urological Institute, Baltimore, MD, USA.
Tracy L RoseLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Division of Medical Oncology, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Marc BjurlinLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Urology, University of North Carolina, Chapel Hill, NC, USA.
Emerson A LimHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA; Spectrum Health Medical Group, Grand Rapids, MI, USA.
Charles G DrakeHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA; Janssen Research and Development, Springhouse, PA, USA.
James M McKiernanHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA; Department of Urology, Columbia University, New York, NY, USA.
Israel DeutschHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA; Department of Radiation Oncology, Columbia University, New York, NY, USA.
Christopher B AndersonHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA; Department of Urology, Columbia University, New York, NY, USA.
Donald L LammBCG Oncology, Phoenix, AZ, USA.
Daniel M GeynismanDepartment of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Elizabeth R PlimackDepartment of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Mark A HallmanDepartment of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Eric M HorwitzDepartment of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Essel Al-SaleemDepartment of Pathology, Fox Chase Cancer Center, Philadelphia, PA, USA.
David Y T ChenDepartment of Urology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Richard E GreenbergDepartment of Urology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Alexander KutikovDepartment of Urology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Gordon GuoDepartment of Radiation Oncology, Indiana University Simon Cancer Center, Indianapolis, IN, USA; University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Timothy A MastersonDepartment of Urology, Indiana University Simon Cancer Center, Indianapolis, IN, USA.
Nabil AdraDivision of Hematology and Oncology, Indiana University Simon Cancer Center, Indianapolis, IN, USA.
Hristos Z KaimakliotisDepartment of Urology, Indiana University Simon Cancer Center, Indianapolis, IN, USA.
Johns Hopkins University · USFox Chase Cancer Center · USIndiana University Health · USColumbia University Irving Medical Center · USBloomberg (United States) · USUniversity of North Carolina at Chapel Hill · USHarvard University · USHoosier Cancer Research Network (United States) · USNRG Oncology · USSidney Kimmel Comprehensive Cancer Center · USSpectrum Health · USSpringhouse · USUniversity of Iowa · USUniversity of Maryland, Baltimore · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder - (ADAPT-BLADDER)R01CA235681 · NCI · JOHNS HOPKINS UNIVERSITY · PI HAHN, NOAH M · 2019 to 2024
$3.2M
Selective histone deacetylase inhibition with entinostat to enhance the anti-tumor immune response to immune checkpoint inhibition in urothelial cancerK08CA248967 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROSE, TRACY L · 2020 to 2022
$787k
NCI NIH HHS K08 CA248967NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA086862NCI NIH HHS R01 CA235681NCI NIH HHS UM1 CA186691
6 · The paper itself

Abstract

backgroundNovel treatments and trial designs remain a high priority for bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) patients.

objectiveTo evaluate the safety and preliminary efficacy of anti-PD-L1 directed therapy with durvalumab (D), durvalumab plus BCG (D + BCG), and durvalumab plus external beam radiation therapy (D + EBRT). DESIGN, SETTING, AND

participantsA multicenter phase 1 trial was conducted at community and academic sites.

interventionPatients received 1120 mg of D intravenously every 3 wk for eight cycles. D + BCG patients also received full-dose intravesical BCG weekly for 6 wk with BCG maintenance recommended. D + EBRT patients received concurrent EBRT (6 Gy × 3 in cycle 1 only). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Post-treatment cystoscopy and urine cytology were performed at 3 and 6 -mo, with bladder biopsies required at the 6-mo evaluation. The recommended phase 2 dose (RP2D) for each regimen was the primary endpoint. Secondary endpoints included toxicity profiles and complete response (CR) rates. RESULTS AND LIMITATIONS: Twenty-eight patients were treated in the D (n = 3), D + BCG (n = 13), and D + EBRT (n = 12) cohorts. Full-dose D, full-dose BCG, and 6 Gy fractions × 3 were determined as the RP2Ds. One patient (4%) experienced a grade 3 dose limiting toxicity event of autoimmune hepatitis. The 3-mo CR occurred in 64% of all patients and in 33%, 85%, and 50% within the D, D + BCG, and D + EBRT cohorts, respectively. Twelve-month CRs were achieved in 46% of all patients and in 73% of D + BCG and 33% of D + EBRT patients.

conclusionsD combined with intravesical BCG or EBRT proved feasible and safe in BCG-unresponsive NMIBC patients. Encouraging preliminary efficacy justifies further study of combination therapy approaches. PATIENT SUMMARY: Durvalumab combination therapy can be safely administered to non-muscle-invasive bladder cancer patients with the goal of increasing durable response rates.

Indexed as

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdministration, IntravesicalAntibodies, MonoclonalBCG VaccineHumansNeoplasm InvasivenessNeoplasm Recurrence, LocalUrinary BladderAdjuvants, ImmunologicAntibodies, MonoclonalBCG VaccinedurvalumabBacillus Calmette-GuerinBacillus Calmette-Guerin unresponsiveBladder cancerClinical trialDurvalumabNon–muscle invasivePD-L1RadiationUrothelial carcinoma

Identifiers

PMID36717286
PMCPMC10192088
OpenAlexW4318387439

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.