SVV-001 + Nivolumab + Ipilimumab for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAman Chauhan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Aman Chauhan, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine: 1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients. 2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients. 3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.

Eligibility Criteria

This trial is for patients with specific types of neuroendocrine tumors: poorly differentiated carcinomas or high-grade, well-differentiated tumors. Details on who can join are not fully provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

Life expectancy of 6 months or greater as assessed by the treating oncologist

I have recovered from side effects of previous treatments, except for hair loss.

I am 18 years old or older.

+6 more

Exclusion Criteria

I haven't had chemotherapy, radiation, or biologic therapy recently.

I have a condition that increases my risk of bleeding from biopsies.

I have a primary immune deficiency or have been taking high-dose steroids or other immune-suppressing drugs recently.

+14 more

Participant Groups

The study tests the Seneca Valley Virus-001 (SVV-001) combined with Nivolumab and Ipilimumab to find the highest safe dose and frequency against neuroendocrine tumors. It aims to match or exceed current treatment effectiveness.

3Treatment groups

Experimental Treatment

Group I: SVV-001 Single Dose Treatment GroupExperimental Treatment3 Interventions

Participants in this group will receive a single dose of SVV-001 on Day 1, in combination with Nivolumab and Ipilimumab therapy. Total participation duration is up to 2 years.

Group II: SVV-001 RP2D Treatment GroupExperimental Treatment3 Interventions

Participants is this group will receive the recommended phase 2 dose and frequency of SVV-001 in combination with Nivolumab and Ipilimumab therapy. Total participation duration is up to 2 years.

Group III: SVV-001 Multi-Dose Treatment GroupExperimental Treatment3 Interventions

Participants in this group will receive multiple doses of SVV-001, beginning on Day 1, in combination with Nivolumab and Ipilimumab therapy. Total participation duration is up to 2 years.