Clinical trial NCT06889493: SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
Official title: A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) Neuroendocrine Tumors
Conditions: Neuroendocrine Carcinoma
Neuroendocrine Tumors
Summary: 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.
Interventions:
description: 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:<br/>* 2.2 × 10^8 Viral Genomes (VG) (starting dose)<br/>* 2.2 × 10^9 VG<br/>* 2.2 × 10^10 VG
name: Seneca Valley Virus-001 (SVV-001)
type: Biological
description: 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.
name: Nivolumab
type: Drug
description: 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.
name: Ipilimumab
type: Drug
Study arms:
design_group_description: Participants in this group will receive a single dose of SVV-001 on Day 1, in combination with Nivolumab and Ipilimumab therapy.<br/>Total participation duration is up to 2 years.
design_group_title: SVV-001 Single Dose Treatment Group
design_group_type: Experimental
design_group_description: Participants in this group will receive multiple doses of SVV-001, beginning on Day 1, in combination with Nivolumab and Ipilimumab therapy.<br/>Total participation duration is up to 2 years.
design_group_title: SVV-001 Multi-Dose Treatment Group
design_group_type: Experimental
design_group_description: Participants is this group will receive the recommended phase 2 dose and frequency of SVV-001 in combination with Nivolumab and Ipilimumab therapy.<br/>Total participation duration is up to 2 years.
design_group_title: SVV-001 RP2D Treatment Group
design_group_type: Experimental
Sponsor: University of Miami
Collaborators: Seneca Therapeutics, Inc.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: NTX-010
lang: EN