Clinical Summary: 

• Design/Population: This trial-in-progress study is evaluating SVV-001, an intratumoral oncolytic Seneca Valley virus, in combination with ipilimumab and nivolumab in patients with high-grade neuroendocrine carcinoma, including small cell lung cancer.
• Key Outcomes: The study is supported by prior preclinical and clinical rationale for SVV-001 and immune checkpoint blockade in a population with limited treatment options. Dose escalation has been completed, and the trial is moving into dose expansion. 
• Clinical Relevance: SVV-001 plus ipilimumab and nivolumab may represent a novel immuno-oncolytic approach for high-grade neuroendocrine carcinoma and small cell lung cancer, with ongoing enrollment intended to further define safety and preliminary efficacy.

Chinmay Jani, MBBS, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, discusses an ongoing phase 1 clinical trial investigating SVV-001, an oncolytic Seneca Valley virus, in combination with ipilimumab and nivolumab for patients with high-grade neuroendocrine carcinomas. The study focuses on a challenging patient population that includes small cell lung cancer and other aggressive neuroendocrine malignancies for which treatment options remain limited.

Following completion of dose escalation, the trial is now entering the dose-expansion phase to further characterize safety and assess preliminary efficacy. By combining intratumoral oncolytic virotherapy with dual checkpoint inhibition, investigators hope to enhance antitumor immune responses and establish a new treatment paradigm for these difficult-to-treat cancers.

Dr Jani presented these results at the 2026 ASCO Annual Meeting in Chicago, Illinois.

Transcript: 

Hi everyone. I’m Chinmay Jani. I’m chief fellow at the University of Miami and Sylvester Comprehensive Cancer Center. I’ll also be joining the faculty in phase 1 experimental therapeutics and thoracic oncology. Today I’m presenting a trial-in-progress abstract.

We are going to talk about a Seneca Valley virus trial focusing on SVV-001, which is an oncolytic picornavirus. It acts through TEM8, and in this trial we are evaluating it in patients with high-grade neuroendocrine carcinomas, including small cell lung cancer.

This patient population has very limited treatment options, particularly after progression on standard therapies. Determining the next line of treatment is often challenging and frequently depends on individual patient factors. 

In our trial, we are evaluating SVV-001 based on encouraging preclinical data as well as findings from prior clinical studies. The study combines Seneca Valley virus with the immunotherapy combination of ipilimumab and nivolumab. The virus itself is administered intratumorally.

We have recently completed the dose-escalation phase of the study and are now moving into the dose-expansion phase. The trial remains open and is actively enrolling patients at the University of Miami.

If you have patients in your clinic, or if patients are listening and know someone with high-grade neuroendocrine carcinoma or small cell lung cancer who may be in need of additional treatment options, we encourage you to reach out to us. We can review eligibility and determine whether enrollment in the trial may be appropriate.

Source: 

Jani C, Reis IM, Modak R, et al. A phase 1 trial of the oncolytic virus SVV-001 with nivolumab and ipilimumab in patients with high-grade neuroendocrine neoplasms. Presented at the ASCO Annual Meeting. May 29 - June 2, 2026. Chicago, Illinois. Abstract 472b.