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Carcinoma, Transitional Cell clinical trials at UCSF
2 in progress, 2 open to new patients

  • A Safety Study of Enfortumab Vedotin Plus Immune Checkpoint Inhibitor Therapy for Patients With Urothelial Bladder Cancer (EV-103)

    open to eligible people ages 18 years and up

    This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8. This study will look at the side effects of giving the two drugs with each other. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with treatment.

    San Francisco, California and other locations

  • Neoadjuvant Atezolizumab in Localized Bladder Cancer

    open to eligible people ages 18 years and up

    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 NMIBC or 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.

    San Francisco, California