NCT03628716

CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CV301	Prime with MVA-BN-CV301 (nominal titer 1.6 x 10\^9 Inf.U) given subcutaneously (SC) on Day 1 and Day 22. One dose = four 0.5 mL injections. One injection = nominal titer 4 x 10\^8 Inf.U in 0.5 mL. Boost with FPV-CV301 (nominal titer of 1 × 10\^9 Inf.U in 0.5 mL, given SC every 21 days for 4 doses (on days 43, 64, 85, and 106), followed by boosts every 6 weeks until 6 months on trial (i.e., days 148 and 190), then every 12 weeks until completion of 2 years. One dose = one 0.5 mL injection.
BIOLOGICAL	Atezolizumab	Atezolizumab fixed dose of 1200 mg intravenous on Day 1 of each 21-day cycle

Timeline

• Start date: 2018-09-18
• Primary completion: 2020-11-03
• Completion: 2021-02-02
• First posted: 2018-08-14
• Last updated: 2022-04-27
• Results posted: 2022-04-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study