Bladder Cancer Clinical Trial
Official title:
A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2). The trial will be performed using an optimal two-stage design within each cohort. Stage 1, Cohort 1: Enroll 14 subjects. If objective response is not achieved in at least four patients, the cohort will be stopped for futility. If objective response is achieved in at least four subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced. Stage 1, Cohort 2: Enroll 13 subjects. If objective response is not achieved in at least three patients, the cohort will be stopped for futility. If objective response is achieved in at least three subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced. Stage 2, Cohort 1: Enroll an additional 19 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 33 patients are evaluable for the primary endpoint. Stage 2, Cohort 2: Enroll an additional 22 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 35 patients are evaluable for the primary endpoint. ;
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