The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer
NCT ID: NCT03577132
Last Updated: 2018-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-08-01
2022-05-31
Brief Summary
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Additionally, along with enormous analysis of genomic landscape of bladder cancer, a consensus was reached regarding the existence of a group of Basal-Squamous-like tumors - designated BASQ - characterized the high expression of KRT5/6 and KRT14 and low/undetectable expression of FOXA1 and GATA3. This novel molecular classification can improve the identification of optimal patient population for different treatment modalities. Specifically, luminal type and basal type may have different treatment response and prognosis after initial definitive treatment, such as neoadjuvant treatments.
However, there is no evidence for this topic, particularly the clinical efficacy of neoadjuvant PD-L1 inhibitors according to the BASQ classification in patients with advanced urothelial bladder cancer.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Luminal type
Luminal type in previous transurethral resection of bladder tumor pathology. Luminal type in Immunohistochemistry (KRT5/6-KRT14-FOXA1+GATA3+)
Neoadjuvant atezolizumab
Atezolimumab
* At a fixed dose of 1200 mg as a 60-minute intravenous infusion (1st), then as a 30-minute intravenous infusion (2nd and 3rd)
* Every 3 weeks, for a total of 3 cycles prior to radical cystectomy
Basal typr
Basal type in previous transurethral resection of bladder tumor pathology. Basal type in Immunohistochemistry (KRT5/6+KRT14+FOXA1-GATA3-)
Neoadjuvant atezolizumab
Atezolimumab
* At a fixed dose of 1200 mg as a 60-minute intravenous infusion (1st), then as a 30-minute intravenous infusion (2nd and 3rd)
* Every 3 weeks, for a total of 3 cycles prior to radical cystectomy
Interventions
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Neoadjuvant atezolizumab
Atezolimumab
* At a fixed dose of 1200 mg as a 60-minute intravenous infusion (1st), then as a 30-minute intravenous infusion (2nd and 3rd)
* Every 3 weeks, for a total of 3 cycles prior to radical cystectomy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed muscle-invasive urothelial carcinoma
* Patients undergoing radical cystectomy
* Advanced status requiring neoadjuvant systemic therapy
* ECOG performance status score of 0 or 1
* Adequate organ and hematologic functions
* Available IHC data for the BASQ classification
Exclusion Criteria
* Active autoimmune disease or inflammatory bowel disease
* Prior severe or persistent immune-related adverse events
* Previous exposure to anti-PD-1 or anti-PD-L1 therapy
* Requirement for 10 mg/d of prednisone or equivalent
* Inadequate liver, kidney function and hematologic dysfunction
* Inoperable case, such as untreated CNS metastases
* No available archival tumor tissue for evaluating the BASQ classification
18 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ja Hyeon Ku
Professor, MD., PHD.
Principal Investigators
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Ja Hyeon Ku, M.D.,PH.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Central Contacts
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References
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Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. doi: 10.1056/NEJMoa022148.
von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, Moore MJ, Zimmermann A, Arning M. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005 Jul 20;23(21):4602-8. doi: 10.1200/JCO.2005.07.757.
Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014 Mar 20;507(7492):315-22. doi: 10.1038/nature12965. Epub 2014 Jan 29.
Choi W, Czerniak B, Ochoa A, Su X, Siefker-Radtke A, Dinney C, McConkey DJ. Intrinsic basal and luminal subtypes of muscle-invasive bladder cancer. Nat Rev Urol. 2014 Jul;11(7):400-10. doi: 10.1038/nrurol.2014.129. Epub 2014 Jun 24.
Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.
Yuk HD, Jeong CW, Kwak C, Kim H, Moon KC, Ku JH. Efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer according to the BASQ classification: a study protocol for an open-label, two-cohort, phase II trial. BMJ Open. 2020 Oct 15;10(10):e035530. doi: 10.1136/bmjopen-2019-035530.
Other Identifiers
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SeoulNUHUro_Atezolizumab
Identifier Type: -
Identifier Source: org_study_id