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

The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer According to the BASQ Classification

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03577132
Enrollment
20
Registered
2018-07-05
Start date
2018-08-01
Completion date
2022-05-31
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Keywords

neoadjuvant chemotherapy, atezolizumab

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.

Interventions

DRUGNeoadjuvant 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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
objective pathological responses (pT0 change)4weeksFinal pathology of bladder after operation (radical cystectomy)

Secondary

MeasureTime frameDescription
progression-free survival at 1yr1yearprogression-free survival at 1yr

Contacts

Primary ContactJa Hyeon Ku, M.D.,PH.D
randyku@hanmail.net+82-2-2072-0361
Backup ContactHyeongdong Yuk, M.D.
hinayuk@naver.com+82-2-2072-1968

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026