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The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03577132
Recruitment Status : Not yet recruiting
First Posted : July 5, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Ja Hyeon Ku, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2018
First Posted Date  ICMJE July 5, 2018
Last Update Posted Date July 31, 2018
Estimated Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
objective pathological responses (pT0 change) [ Time Frame: 4weeks ]
Final pathology of bladder after operation (radical cystectomy)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
progression-free survival at 1yr [ Time Frame: 1year ]
progression-free survival at 1yr
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer
Official Title  ICMJE The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer According to the BASQ Classification
Brief Summary

Recently, promising evidences that blocking PD-1 and PD-L1 is an efficacious way to treat advanced stage bladder cancer patients. Atezolimumab is the first PD-L1 inhibitor approved by US FDA for advanced UBC in June 2014. These novel agents will become the standard therapy for unhopeful UBC patients who fail to respond to cisplatin-based chemotherapy and finally, the first-line treatment would be changed from cisplatin-based chemotherapy to immune check point inhibitors for advanced UBC, particularly neoadjuvant setting.

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE Drug: 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
Study Arms  ICMJE
  • Experimental: Luminal type
    Luminal type in previous transurethral resection of bladder tumor pathology. Luminal type in Immunohistochemistry (KRT5/6-KRT14-FOXA1+GATA3+)
    Intervention: Drug: Neoadjuvant atezolizumab
  • Experimental: Basal typr
    Basal type in previous transurethral resection of bladder tumor pathology. Basal type in Immunohistochemistry (KRT5/6+KRT14+FOXA1-GATA3-)
    Intervention: Drug: Neoadjuvant atezolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years of age
  • 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:

  • Non-urothelial carcinoma histology
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ja Hyeon Ku, M.D.,PH.D +82-2-2072-0361 randyku@hanmail.net
Contact: Hyeongdong Yuk, M.D. +82-2-2072-1968 hinayuk@naver.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03577132
Other Study ID Numbers  ICMJE SeoulNUHUro_Atezolizumab
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ja Hyeon Ku, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ja Hyeon Ku, M.D.,PH.D Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP