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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Bavarian Nordic
Study ID
NCT03628716
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CV301 — BIOLOGICAL
    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.
  • Atezolizumab — BIOLOGICAL
    Atezolizumab fixed dose of 1200 mg intravenous on Day 1 of each 21-day cycle

Study Details

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).

Key Dates

Start date
Sep 18, 2018
Status verified
Mar 2022
Primary completion
Nov 3, 2020
Completion
Feb 2, 2021

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CV301 + Atezolizumab
    Subject receiving combination treatment with CV301 + Atezolizumab

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research Institute, Inc.TampaFlorida33612-
Norton Cancer Institute, Norton Healthcare PavilionLouisvilleKentucky40202-
Dana Farber Cancer Institute (DFCI)BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
H. Lee Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLNorton Cancer Institute, Norton Healthcare Pavilion· Louisville, KYDana Farber Cancer Institute (DFCI)· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Utah - Huntsman Cancer Institute· Salt Lake City, UTSeattle Cancer Care Alliance· Seattle, WA

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