Actively Recruiting
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
Led by Peter Hosein, MD · Updated on 2026-04-28
36
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
P
Peter Hosein, MD
Lead Sponsor
S
Seneca Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older
- Life expectancy of at least 6 months
- Advanced metastatic disease progressed after at least one prior therapy
- Confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor or poorly differentiated neuroendocrine carcinoma
- Radiological confirmation of tumor for patients in Part 1A
- Measurable disease suitable for multiple SVV-001 injections for Parts 1B and 2
- ECOG performance status of 0 or 1
- Recovery to Grade 1 or baseline from prior treatment toxicities (excluding hair loss)
- Adequate liver, kidney, and blood function
- Archival tissue available or biopsy if needed for Part 2 patients
- Women of childbearing potential and men must agree to use contraception during treatment and for 7 months after
- Willingness and ability to comply with all study procedures
- Provide written informed consent
You will not qualify if you...
- Active second cancer within 2 years unless cured by surgery
- Recent cytotoxic chemotherapy, radiation, or biologic therapies within defined timeframes
- Major surgery or significant injury within 28 days before treatment
- Physical abnormalities increasing biopsy or injection risks
- Live-virus vaccination within 30 days before or during the study
- Active autoimmune or inflammatory disease requiring systemic treatment recently or severe history
- Primary immunodeficiency or recent immunosuppressive therapy
- Active infections including HIV, hepatitis B or C
- History of solid-organ or bone marrow transplant
- Allergies to ipilimumab, nivolumab, or their components
- Untreated central nervous system metastases
- Significant recent cardiovascular disease or reduced heart function
- Low oxygen saturation below 92% on room air
- Serious chronic illness or psychiatric condition affecting participation
- Breastfeeding or positive pregnancy test before treatment
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
P
Peter Hosein, MD
CONTACT
N
Nailet Real Bestard, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here