SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

May 19, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2030

Conditions
Neuroendocrine CarcinomaNeuroendocrine Tumors
Interventions
BIOLOGICAL

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"

DRUG

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.

DRUG

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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Seneca Therapeutics

UNKNOWN

lead

Aman Chauhan, MD

OTHER