Trial of SVV-001, Opdivo and Yervoy in Neuroendocrine Tumors Launching

A phase 1 clinical trial is now open for enrollment to patients with high-grade neuroendocrine tumors to receive treatment with a combination of immunotherapy and what has been described in a news release as a tumor-busing oncolytic virus injected directly into a tumor.

The trial was announced in a news release issued by the Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine.

Headed by Dr. Aman Chauhan, who is the leader of the Neuroendocrine Tumor Program at Sylvester, the trial is looking to eventually enroll 36 patients, according to its listing on clinicaltrials.gov. The trial is expected to be completed on approximately May 1, 2030.

In the trial, patients will receive treatment with Opdivo (nivolumab), Yervoy (Ipilimumab) and Seneca Valley Virus-001 (SVV-001), according to the listing. The trial is intended to determine the highest dose and highest frequency of dosing of the trial regimen that are tolerated by patients, and the highest dose and frequency of dosing of the regimen that target neuroendocrine tumors with at least the same degree of effectiveness and tolerability as current standard-of-care treatments.

According to the news release, patients with high-grade neuroendocrine cancer currently have few treatment options beyond conventional chemotherapy.

Neuroendocrine tumors, as explained by the news release, originate from cells that are found throughout the body and can affect most organ systems, and most often affect the lungs, gastrointestinal tract, gynecological tract and prostate, with about one in six neuroendocrine tumors classified as high grade.

In the trial, patients whose disease has become resistant to or failed previous lines of therapy will receive treatment with SVV—a virus that, according to the news release, grows inside tumor cells and causes them to burst open. When the tumor cells burst, they release their contents, which activates the immune system, and the virus infects other tumors in order to continue the chain reaction.

Opdivo, as defined by the National Cancer Institute on its website, works by binding to and blocking the protein PD-1 on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system and allows the immune system to attack cancer cells. Likewise, Yervoy binds to and may block the protein CTLA-4 to help immune cells kill cancer cells better, as the National Cancer Institute explained.

In order to participate in the trial, some inclusion criteria include that patients must be 18 years old or older, have a life expectancy of six months or longer, have advanced metastatic disease that has progressed on at least one prior line of available therapy and have a confirmed diagnosis of grade 3 well-differentiated neuroendocrine tumor or poorly differentiated neuroendocrine carcinoma.

More About Neuroendocrine Tumors

Neuroendocrine tumors, as explained by the National Cancer Institute on its website, grow from neuroendocrine cells, which send and receive messages through hormones to help the body function and are found in organs throughout the body.

These tumors often grow very slowly and in children and young adults are most often found in the appendix (appendiceal neuroendocrine tumors) or in the lungs (bronchial tumors), the National Cancer Institute explained, while in adults they are most often found in the digestive tract (GI NET). Estimates are that these tumors affect approximately four in every 100,000 adults, while they are too rare in children and young adults for there to be data on how many young people are affected by them.

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