Evidence map›Paper›PMID 28375787›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study.

Andrea B Apolo, Jeffrey R Infante, Ani Balmanoukian, Manish R Patel, Ding Wang, Karen Kelly, Anthony E Mega, Carolyn D Britten, Alain Ravaud, Alain C Mita and 7 more

4 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 316 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
316citing papers in PubMed, 15 pooled it
87.1field-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.

NCT01772004 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2013 to 2019Enrolled1,756ConditionsSolid TumorsArmsAvelumab
NCT03390595 phase2completednot on this mapstarted 2018, after this paper: background citation

Phase II Multicentre, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Avelumab With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Unresectable or Metastatic Urothelial Carcinoma (UC) Who Have Not Received Prior Systemic Therapy and Who Are Ineligible to Receive Cisplatin-based Therapy.

TypeinterventionalSponsorAssociació per a la Recerca Oncologica, SpainRan2018 to 2022Enrolled85ConditionsMetastatic Urothelial CancerArmsavelumab 10mg/kg with carboplatin/gemcitabine, carboplatin/gemcitabine alone
NCT04360941 phase1active not recruitingnot on this mapstarted 2020, after this paper: background citation

PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2020 to 2027Enrolled45ConditionsTriple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast CancerArmsPalbociclib, Avelumab
NCT05700344 completednot on this mapstarted 2022, after this paper: background citation

Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

TypeobservationalSponsorSpanish Oncology Genito-Urinary GroupRan2022 to 2023Enrolled125ConditionsMetastatic Urothelial CarcinomaArmsAvelumab
3 · Its place in the literature

Who cites it

316 citing papers in PubMed, 15 syntheses or guidelines pooled it, 581 citations in OpenAlex.

  1. Pooled it
  2. Immunotherapy for advanced or metastatic urothelial carcinoma.The Cochrane database of systematic reviews · 2023
    Pooled it
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  5. Switch Maintenance Therapy for Metastatic Urothelial Carcinoma.Bladder cancer (Amsterdam, Netherlands) · 2022
    Pooled it
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  12. The efficacy and safety of immunotherapy targeting the PD-1 pathway for advanced urothelial carcinoma: a meta-analysis of published clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Pooled it
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  19. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase 1 Trial.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020
    Trial
  20. Trial

256 more citing papers are in PubMed but not listed here.

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

17 authors at 2 institutions in 2 countries.

Andrea B ApoloAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Jeffrey R InfanteAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Ani BalmanoukianAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Manish R PatelAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Ding WangAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Karen KellyAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Anthony E MegaAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Carolyn D BrittenAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Alain RavaudAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Alain C MitaAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Howard SafranAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Thomas E StinchcombeAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Marko SrdanovAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Arnold B GelbAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Michael SchlichtingAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Kevin ChinAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
James L GulleyAndrea B. Apolo and James L. Gulley, National Institutes of Health, Bethesda, MD; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Ani Balmanoukian, The Angeles Clinic & Research Institute; Alain C. Mita, Cedars Sinai Medical Center, Los Angeles; Karen Kelly, University of California-Davis, Sacramento; Marko Srdanov, Dako North America, Carpinteria, CA; Manish R. Patel, Florida Cancer Specialists & Research Institute, Sarasota, FL; Ding Wang, Henry Ford Hospital, Detroit, MI; Anthony E. Mega, The Warren Alpert Medical School at Brown University; Howard Safran, The Miriam Hospital, Providence; Howard Safran, Newport Hospital, Newport, RI; Carolyn D. Britten, Medical University of South Carolina, Charleston, SC; Alain Ravaud, CHU de Bordeaux, Bordeaux, France; Thomas E. Stinchcombe, Duke University Medical Center, Durham, NC; Arnold B. Gelb and Kevin Chin, EMD Serono, Billerica, MA; and Michael Schlichting, Merck, Darmstadt, Germany.
Spanish Oncology Genitourinary Group · ESCardinal Glennon Children’s Medical Center · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Translational Science Laboratory Shared ResourceP30CA138313 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI RAYMOND N. DUBOIS · 2009 to 2026
$42.7M
Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Bladder Cancer ProgramZIABC011351 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2010 to 2025
$9.4M
NCATS NIH HHS UL1 TR002384NCI NIH HHS P30 CA138313
6 · The paper itself

Abstract

Purpose We assessed the safety and antitumor activity of avelumab, a fully human anti-programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma. Methods In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), progression-free survival, overall survival (OS), and PD-L1-associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells. Results Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1-positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%). Conclusion Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCohort StudiesDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedTreatment OutcomeUrologic NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedavelumab

Identifiers

PMID28375787
PMCPMC5493051
OpenAlexW2604441970

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.