36
Participants
Start Date
May 19, 2025
Primary Completion Date
June 1, 2030
Study Completion Date
June 1, 2030
Seneca Valley Virus-001 (SVV-001)
"SVV-001 will be administered intratumorally as a single dose on Day 1; or as multiple doses on Days 1, 15, 29, 43, 57, and 71. The virus dose levels per SVV-001 treatment are as follows:~* 2.2 × 10\^8 Viral Genomes (VG) (starting dose)~* 2.2 × 10\^9 VG~* 2.2 × 10\^10 VG"
Nivolumab
Nivolumab will be administered via intravenous (IV) injection at a dose of 240 mg, once every two weeks starting on Day 15 until Day 85 during SVV-001 therapy. Nivolumab will be administered once every four weeks during the maintenance period for up to 2 years.
Ipilimumab
Ipilimumab will be administered via intravenous (IV) injection at a dose of 1 mg/kg, once every six weeks starting on Day 15 until Day 85 during SVV-001 therapy. Participants will continue on 1 mg/kg ipilimumab IV every 6 weeks for two additional doses or unacceptable toxicity and/or participant withdrawal.
RECRUITING
University of Miami, Miami
Collaborators (1)
Seneca Therapeutics
UNKNOWN
Aman Chauhan, MD
OTHER