Neoadjuvant Atezolizumab in Localized Bladder Cancer
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a single arm, open label Phase II study of MPDL3280A, an anti-PD-L1 antibody
administered as neoadjuvant therapy to subjects with either BCG-refractory non-muscle
invasive transitional cell carcinoma (TCC) of the bladder, or muscle-invasive TCC appropriate
for cystectomy and refusing or ineligible for neoadjuvant chemotherapy. Enrolled patients
will be assigned sequentially to dose levels in cohorts of 6 patients per dose level. The
starting dose level is 1200mg x 1 dose and will be escalated in subsequent cohorts to 1200mg
q 3 weeks x 2 doses, and finally 1200mg q 3 weeks x 3 doses to determine the impact of
increasing number of treatments on the modulated immune response with the tumor tissue.
Subjects with adverse pathology (pT3/pT4 or N+) will be offered the option of adjuvant
MPDL3280A for up to 16 cumulative cycles of treatment.
After all neoadjuvant study therapy is administered, each subject will undergo cystectomy to
evaluate pathologic response to treatment and for immunologic characterization in the
resected tissue. Serum and urine will be obtained as well to characterize circulating immune
responses. After the multi-dose portion of the study has completed accrual two expansion
cohorts of up to 15 patients each with Non-muscle-invasive bladder cancer (NMIBC) or
Non-metastatic muscle-invasive bladder cancer (MIBC) will be accrued at the highest dose
level for further characterization of safety, efficacy, and immunologic analysis. Patients
with pT3, pT4, or N+ disease at the time of cystectomy and no metastatic disease will be
offered the option of adjuvant MPDL3280A for up to a total of 16 cumulative cycles. All
subjects will be followed clinically for up to 2 years to assess for disease recurrence.
Phase:
Phase 2
Details
Lead Sponsor:
Lawrence Fong University of California, San Francisco
Collaborators:
Conquer Cancer Foundation Genentech, Inc. The Bladder Cancer Advocacy Network