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

Part of paid clinical trials in Miami, Florida.

Sponsor
Peter Hosein, MD
Study ID
NCT06889493
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Seneca Valley Virus-001 (SVV-001) — BIOLOGICAL
    SVV-001 will be administered intratumorally as a single dose on Day 1; or as multiple doses on Days 1, 15, 29, 43, 57, and 71. The virus dose levels per SVV-001 treatment are as follows: * 2.2 × 10\^8 Viral Genomes (VG) (starting dose) * 2.2 × 10\^9 VG * 2.2 × 10\^10 VG
  • Nivolumab — DRUG
    Nivolumab will be administered via intravenous (IV) injection at a dose of 240 mg, once every two weeks starting on Day 15 until Day 85 during SVV-001 therapy. Nivolumab will be administered once every four weeks during the maintenance period for up to 2 years.
  • Ipilimumab — DRUG
    Ipilimumab will be administered via intravenous (IV) injection at a dose of 1 mg/kg, once every six weeks starting on Day 15 until Day 85 during SVV-001 therapy. Participants will continue on 1 mg/kg ipilimumab IV every 6 weeks for two additional doses or unacceptable toxicity and/or participant withdrawal.

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
Apr 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SVV-001 Single Dose Treatment Group
    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.
  • Experimental: SVV-001 Multi-Dose Treatment Group
    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.
  • Experimental: SVV-001 RP2D Treatment Group
    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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Peter Hosein, MD
[email protected]
305-243-3462
Nailet Real Bestard, MS
[email protected]
+1 (305) 2438173
Peter Hosein, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
University of Miami· Miami, FL

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