A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER
- Conditions
- lokaal gevorderd of gemetastaseerde urotheliale blaaskankerbladder cancerlocally advanced or metastatic urothelial bladder cancer
- Registration Number
- NL-OMON44787
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
• Histologically or cytologically documented locally advanced (T4b, any N; or any T, N 2*3) or metastatic (M1, Stage IV) TCC (also termed urothelial cell carcinoma) of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to have sufficient viable tumor content prior to study enrollment; tumor specimens will be evaluated for PD-L1 expression; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patients with ECOG 2 are allowed in Cohort 1.
• Measurable disease, as defined by RECIST v1.1 Previously irradiated lesions should not be counted as target lesions.;Cohort 1-Specific Inclusion Criteria
• No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UBC
• Ineligible (*unfit*) for cisplatin-based chemotherapy as defined by any one of the following criteria:
- Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 mL/min). GFR should be assessed by direct measurement (i.e., creatinine clearance or ethyldediaminetetra-acetate) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula)
- A hearing loss (measured by audiometry) of 25 dB at two contiguous frequencies
- Grade 2 or greater peripheral neuropathy (i.e., sensory alteration or parasthesis including tingling)
- ECOG performance score of 2;Cohort 2-Specific Inclusion Criteria
• Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
Cancer Specific Exclusion Criteria
• Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
• Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
• Leptomeningeal disease;Medication-Related Exclusion Criteria:
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
• Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
• Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome measures are as follows:<br /><br><br /><br>• IRF-assessed objective response according to RECIST v1.1<br /><br>• Investigator-assessed objective response according to modified RECIST (this<br /><br>is applicable only to Cohort 2)<br /><br><br /><br>An objective response is defined as a confirmed PR or CR. Modified RECIST<br /><br>outcomes, which incorporate the measurement of new lesions, are described in<br /><br>detail in Appendix 3. The ORR is defined as the proportion</p><br>
- Secondary Outcome Measures
Name Time Method