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

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 18, 2018

Primary Completion Date

November 3, 2020

Study Completion Date

February 2, 2021

Conditions
Bladder Cancer
Interventions
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

Trial Locations (6)

33612

H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa

40202

Norton Cancer Institute, Norton Healthcare Pavilion, Louisville

84112

University of Utah - Huntsman Cancer Institute, Salt Lake City

98109

Seattle Cancer Care Alliance, Seattle

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute (DFCI), Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bavarian Nordic

INDUSTRY

NCT03628716 - CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer | Biotech Hunter | Biotech Hunter