NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Trials In Progress Section (15 abstracts)
A Phase 1 Trial of the Oncolytic Virus SVV-001 with Nivolumab and Ipilimumab in Patients with High Grade Neuroendocrine Neoplasms
Aman Chauhan 1 , Isildinha M Reis 1 , Chinmay Jani 1 , Rakhi Modak 1 , Daniel Bilbao Cortes 1 , Stephanie Baboun 1 , Alexander Rivera 1 , Hung Trinh 2 , Paul Hallenbeck 2 , Jaime Merchan 1 , Gilberto Lopes 1 & Peter Hosein 1
1Sylvester Cancer Center, University of Miami; 2Seneca Therapeutics
Background: High-grade neuroendocrine neoplasms (NENs), including poorly differentiated neuroendocrine carcinomas (NECs) and well-differentiated grade 3 neuroendocrine tumors (NETs), are aggressive malignancies with limited effective treatment options. Immune checkpoint inhibitors (ICIs) have demonstrated limited clinical activity in these tumors. Seneca Valley Virus (SVV-001) is a novel oncolytic RNA virus that has shown synergistic activity with ICIs in preclinical models. Additionally, SVV-001 has been observed to reverse CPI resistance in vivo, supporting its evaluation in combination with nivolumab and ipilimumab.
Methods: This is an investigator-initiated, phase 1, dose-escalation and cohort-expansion study evaluating intratumoral SVV-001 in combination with nivolumab and ipilimumab in patients with histologically confirmed poorly differentiated NEC or well-differentiated grade 3 NET. The trial was activated in March 2025, with patient enrollment currently ongoing and a target of up to 36 patients. A standard 3+3 dose-escalation design is being employed to determine the recommended phase 2 dose (RP2D). Following dose escalation, an expansion cohort will further evaluate safety and preliminary signals of activity. Tumor endothelial marker 8 (TEM8), a potential biomarker of SVV-001 sensitivity, will be assessed as part of correlative studies. NCT06889493
Results: This Phase 1 trial is active at University of Miami and plans to expand the trial to other cancer centers in the US.
Conclusions: N/A
Abstract ID #33468
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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