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OncoMatch/Clinical Trials/NCT06889493

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

Is NCT06889493 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Seneca Valley Virus-001 (SVV-001) and Nivolumab for neuroendocrine carcinoma.

Phase 1RecruitingPeter Hosein, MDNCT06889493Data as of May 2026

Treatment: Seneca Valley Virus-001 (SVV-001) · Nivolumab · IpilimumabThe 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.

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Extracted eligibility criteria

Cancer type

Neuroendocrine Tumor

Disease stage

Required: Stage ADVANCED METASTATIC

Metastatic disease required

Grade: 3

advanced metastatic disease that has progressed on at least one line of available therapy

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: any available therapy

disease that has progressed on at least one line of available therapy

Cannot have received: cytotoxic chemotherapy

Has had cytotoxic chemotherapy or radiation therapy within 3 weeks

Cannot have received: radiation therapy

Has had cytotoxic chemotherapy or radiation therapy within 3 weeks

Cannot have received: biologic therapy

less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001

Lab requirements

Blood counts

ANC ≥1500 cells/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9.0 g/dL; INR within institutional normal range; Normal PT and PTT

Kidney function

Creatinine clearance ≥50 mL/minute using Cockcroft Gault equation

Liver function

ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)

Cardiac function

Patients with an ejection fraction (EF) < 50 on a 2D echocardiogram (ECHO) excluded

Adequate hematological, renal, and liver function defined as follows: ... ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis); Creatinine clearance ≥50 mL/minute using Cockcroft Gault equation; ANC ≥1500 cells/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9.0 g/dL; INR within institutional normal range; Normal PT and PTT. Patients with an ejection fraction (EF) < 50 on a 2D echocardiogram (ECHO) excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Miami · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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