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SVV-001 with Nivolumab and Ipilimumab for Neuroendocrine Cancers

This study is testing a new combination of treatments for advanced neuroendocrine carcinoma (NEC) or well-differentiated high-grade neuroendocrine tumors (NET). You might be eligible if you are 18 or older, have a life expectancy of at least 6 months, and your cancer has progressed after at least one previous treatment. The study will use Seneca Valley Virus-001 (SVV-001), which is given directly into the tumor, along with two other drugs, Nivolumab and Ipilimumab, given through a vein. Researchers want to find the highest dose and frequency of SVV-001 that is safe and well-tolerated when combined with Nivolumab and Ipilimumab. They also want to see if this combination is as effective and tolerable as current standard treatments.

Study design
This is an interventional study with a planned enrollment of 36 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for up to 12 months to assess side effects and how well the treatment is tolerated.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06889493

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Peter Hosein, MD
~36 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Seneca Valley Virus-001 (SVV-001)NivolumabIpilimumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose
Measured over Up to 12 months
+3 more outcomes measured

Conditions

Neuroendocrine Carcinoma
Neuroendocrine Tumors

Explore related trials

Neuroendocrine CarcinomaNeuroendocrine Neoplasm

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Peter Hosein, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Peter Hosein, MD
[email protected]
+1 (305) 2438173
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

a. Hepatic:
i. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN if liver metastases are present)
ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
b. Renal:
i. Creatinine clearance ≥50 mL/minute using Cockcroft Gault equation
c. Hematologic:
i. Absolute neutrophil count ≥1500 cells/µL
ii. Platelet count ≥100,000 platelets/µL
iii. Hemoglobin ≥9.0 g/dL
iv. International normalization ratio (INR) within the institutional normal range
v. Normal prothrombin time (PT) and partial thromboplastin time (PTT) 10. For Part 2 Expansion Cohort patients only, patients will submit archival tissue at Screening and undergo a post-treatment biopsy according to the treating institution's guidelines with the following exceptions:
a. If an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening, at the PI's discretion, a screening biopsy will be ordered.
b. Participants will not undergo a biopsy procedure for collection of the post-treatment biopsy if, in the discretion of their treating physician, the participant's condition has deteriorated to the point where performance of a biopsy procedure would place the participant at an increased risk for complications beyond what is reasonably expected for a biopsy collected as part of the participant's standard medical care. 11. Women of childbearing potential must agree to use a reliable form of contraceptive during the trial treatment period and for at least 7 months following the last dose of IMP. 12. Male patients must agree to use an adequate method of contraception during the trial treatment period and for at least 7 months following the last dose of IMP. 13. Patient is willing and able to comply with all protocol-required assessments, visits, and procedures. 14. Provide written informed consent prior to performing any trial-related procedure.

What this trial measures

  • Maximum Tolerated Dose (MTD)/Recommended Phase 2 DoseUp to 12 months

    MTD is defined as the highest dose of SVV-001 evaluated for which estimated toxicity rate is the closest to the target toxicity rate as assessed by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The MTD will be established as the recommended phase 2 dose (RP2D).

  • Number of Participants Experiencing Dose Limiting Toxicities (DLTs): Part 1 OnlyUp to 12 months

    The number of participants experiencing dose limiting toxicities (DLTs) in Part 1 will be reported. DLTs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

  • Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)Up to 12 months

    The number of participants experiencing treatment-related serious adverse events (SAEs) after starting study therapy will be reported. SAEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

  • Number of Participants Experiencing Treatment-Related Adverse Events (AEs)Up to 12 months

    The number of participants experiencing treatment-related adverse events after starting study therapy will be reported. AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.