Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Neoadjuvant atezolizumab Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer According to the BASQ Classification
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Luminal type
Luminal type in previous transurethral resection of bladder tumor pathology. Luminal type in Immunohistochemistry (KRT5/6-KRT14-FOXA1+GATA3+)
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

Experimental: Basal typr
Basal type in previous transurethral resection of bladder tumor pathology. Basal type in Immunohistochemistry (KRT5/6+KRT14+FOXA1-GATA3-)
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




Primary Outcome Measures :
  1. objective pathological responses (pT0 change) [ Time Frame: 4weeks ]
    Final pathology of bladder after operation (radical cystectomy)


Secondary Outcome Measures :
  1. progression-free survival at 1yr [ Time Frame: 1year ]
    progression-free survival at 1yr



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577132


Contacts
Layout table for location contacts
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

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ja Hyeon Ku, M.D.,PH.D Seoul National University Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ja Hyeon Ku, Professor, MD., PHD., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03577132    
Other Study ID Numbers: SeoulNUHUro_Atezolizumab
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ja Hyeon Ku, Seoul National University Hospital:
neoadjuvant chemotherapy
atezolizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Atezolizumab
Antineoplastic Agents