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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective study|
|Masking:||None (Open Label)|
|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|
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
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
- objective pathological responses (pT0 change) [ Time Frame: 4weeks ]Final pathology of bladder after operation (radical cystectomy)
- progression-free survival at 1yr [ Time Frame: 1year ]progression-free survival at 1yr
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
|Contact: Ja Hyeon Ku, M.D.,PH.Dfirstname.lastname@example.org|
|Contact: Hyeongdong Yuk, M.D.||+email@example.com|
|Principal Investigator:||Ja Hyeon Ku, M.D.,PH.D||Seoul National University Hospital|