Neuroendocrine CarcinomaPhase 1NCT06889493
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
A Phase 1 study testing Seneca Valley Virus-001 (SVV-001), Nivolumab and Ipilimumab in people with Neuroendocrine Carcinoma and Neuroendocrine Tumors, run by Peter Hosein, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinoma, Neuroendocrine Tumors
- What is being tested?
- Seneca Valley Virus-001 (SVV-001), Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 1 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 18 years of age or older at the time of consent.
- Life expectancy of 6 months or greater as assessed by the treating oncologist.
- Have advanced metastatic disease that has progressed on at least one line of available therapy.
- Histologically or cytologically confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor (NET) or poorly differentiated neuroendocrine carcinoma (NEC; large-cell neuroendocrine carcinoma, small-cell carcinoma, mixed neuroendocrine non neuroendocrine carcinoma). Note: if an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening for diagnostic confirmation, at the Principal Investigator's (PI's) discretion, a screening biopsy will be ordered.
- For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor is required.
- Parts 1B and 2 only: Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or immune-related Response Evaluation Criteria in Solid Tumors (iRECIST). At least one lesion must be suitable for multiple injections (up to 6 injections every 2 weeks) with SVV-001. Lesions for injection must be ≥10 mm in longest diameter and deemed safe and suitable for injection by the Investigator.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Recovered to Grade 1 or baseline from any clinically significant toxicity associated with prior treatments (excluding alopecia) prior to initiation of investigational medicinal product (IMP) administration.
- Adequate hematological, renal, and liver function defined as follows:
- 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)
- 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.
- 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.
- 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.
- Patient is willing and able to comply with all protocol-required assessments, visits, and procedures.
- Provide written informed consent prior to performing any trial-related procedure.
Who cannot join
- Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such as in situ cervical cancer or squamous cell cancer of the skin.
- Has had cytotoxic chemotherapy or radiation therapy within 3 weeks; and less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001.
- Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of SVV-001.
- Has any physical abnormality of the tissue/organ to be biopsied that would put the patient at increased risk of bleeding secondary to the injection and/or biopsy.
- Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the trial or within 30 days of the last treatment with IMP.
- Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not result in exclusion from the trial.
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- Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of SVV-001.
- Any active infection, including known infection with human immunodeficiency virus (HIV), active hepatitis, or seropositive for hepatis B immunoglobulin (Ig) M core antibody or hepatitis C ribonucleic acid (RNA) at the screening visit.
- Patients with a history of solid-organ or bone marrow transplant.
- Known hypersensitivity to ipilimumab or nivolumab or their excipients
- Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible as long as they are stable and there is no evidence of progression for at least 4 weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT)) during the screening period.
- Any clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Patients with an ejection fraction (EF) < 50 on a 2D echocardiogram (ECHO).
- Patients whose baseline pulse oximetry (saturation of peripheral oxygen (SpO2)) is < 92% on Room air.
- Any chronic illness, psychiatric condition, or social situation that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance or would place the patient at an unacceptable risk and/or have the potential to affect interpretation of the results of the trial.
- Female participants who are breastfeeding and/or who have a positive pregnancy test result prior to receiving any treatment with IMP.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Peter Hosein, MD, 305-243-3462, PHosein@med.miami.edu
Nailet Real Bestard, MS, +1 (305) 2438173, nxr518@med.miami.edu
About this study
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
The purpose of this study is to determine:
- The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
- The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
- 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
- Neuroendocrine Carcinoma, Neuroendocrine Tumors
- Being tested
- Seneca Valley Virus-001 (SVV-001), Nivolumab, Ipilimumab
- Medical subject headings
- Carcinoma, Neuroendocrine, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
NivolumabDrug
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.
IpilimumabDrug
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 group | Role | What they receive |
|---|---|---|
| SVV-001 Single Dose Treatment Group | Experimental | 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. Receives: Biological: Seneca Valley Virus-001 (SVV-001); Drug: Nivolumab; Drug: Ipilimumab |
| SVV-001 Multi-Dose Treatment Group | Experimental | 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. Receives: Biological: Seneca Valley Virus-001 (SVV-001); Drug: Nivolumab; Drug: Ipilimumab |
| SVV-001 RP2D Treatment Group | Experimental | 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. Receives: Biological: Seneca Valley Virus-001 (SVV-001); Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose
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).
Measured: Up to 12 months
Number of Participants Experiencing Dose Limiting Toxicities (DLTs): Part 1 Only
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.
Measured: Up to 12 months
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
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.
Measured: Up to 12 months
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
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.
Measured: Up to 12 months
Secondary outcomes (7)
Progression-Free Survival (PFS) Measured by RECIST
Progression-Free Survival (PFS) among study participants will be reported. PFS will be assessed in months (6 and 12 months) from start of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 12 months
Progression-Free Survival (PFS) Measured by iRECIST
Progression-Free Survival (PFS) among study participants will be reported. PFS will be assessed in months (6 and 12 months) from start of treatment according to immune-related Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Up to 12 months
Overall Response Rate (ORR) Measured by RECIST
ORR is defined as percentage of evaluable patients achieving complete response (CR) or partial response (PR), as best responses according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 12 months
Overall Response Rate (ORR) Measured by iRECIST
ORR is defined as percentage of evaluable patients achieving complete response (CR) or partial response (PR), as best responses according to immune-related Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Up to 12 months
Duration of Response (DOR)
Duration of overall response is defined as time in months from date of onset of response (the first documentation of partial response (PR) or complete response (CR)) to the date of first disease progression after initiation to study therapy.
Measured: Up to 2 years
Clinical Benefit Rate (CBR) Measured by RECIST
Clinical benefit rate (CBR) is defined as percentage of evaluable patients achieving complete response (CR) or partial response (PR) or stable disease (SD) as best response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 12 months
Clinical Benefit Rate (CBR) Measured by iRECIST
Clinical benefit rate (CBR) is defined as percentage of evaluable patients achieving complete response (CR) or partial response (PR) or stable disease (SD) as best response, according to immune-related Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 May 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Hosein, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Seneca Therapeutics
- Responsible party
- Sponsor-investigator, Peter Hosein, MD, University of Miami Sylvester Comprehensive Cancer Center
- Investigators
- Peter Hosein, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889493
- Sponsor's protocol ID
- 20231325
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06889493
- Acronym / sponsor ID
- 20231325
- Conditions
- Neuroendocrine Carcinoma, Neuroendocrine Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peter Hosein, MDUniversity, hospital or other
- Collaborators
- Seneca Therapeutics
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine:
- The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
- The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SVV-001 Single Dose Treatment Group | Experimental | Biological: Seneca Valley Virus-001 (SVV-001), Drug: Nivolumab, Drug: IpilimumabParticipants 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. |
| SVV-001 Multi-Dose Treatment Group | Experimental | Biological: Seneca Valley Virus-001 (SVV-001), Drug: Nivolumab, Drug: IpilimumabParticipants 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. |
| SVV-001 RP2D Treatment Group | Experimental | Biological: Seneca Valley Virus-001 (SVV-001), Drug: Nivolumab, Drug: IpilimumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female patients, 18 years of age or older at the time of consent.
- Life expectancy of 6 months or greater as assessed by the treating oncologist.
- Have advanced metastatic disease that has progressed on at least one line of available therapy.
- Histologically or cytologically confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor (NET) or poorly differentiated neuroendocrine carcinoma (NEC; large-cell neuroendocrine carcinoma, small-cell carcinoma, mixed neuroendocrine non neuroendocrine carcinoma). Note: if an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening for diagnostic confirmation, at the Principal Investigator's (PI's) discretion, a screening biopsy will be ordered.
- For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor is required.
Key exclusion criteria (17 listed)
- Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such as in situ cervical cancer or squamous cell cancer of the skin.
- Has had cytotoxic chemotherapy or radiation therapy within 3 weeks; and less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001.
- Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of SVV-001.
- Has any physical abnormality of the tissue/organ to be biopsied that would put the patient at increased risk of bleeding secondary to the injection and/or biopsy.
- Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the trial or within 30 days of the last treatment with IMP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seneca Valley Virus-001 (SVV-001)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 | Biological | SVV-001 Multi-Dose Treatment Group, SVV-001 RP2D Treatment Group, SVV-001 Single Dose Treatment Group |
| NivolumabNivolumab 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. | Drug | SVV-001 Multi-Dose Treatment Group, SVV-001 RP2D Treatment Group, SVV-001 Single Dose Treatment Group |
| IpilimumabIpilimumab 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. | Drug | SVV-001 Multi-Dose Treatment Group, SVV-001 RP2D Treatment Group, SVV-001 Single Dose Treatment Group |
Primary outcome
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose
Time frame: Up 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 Only
Time frame: Up 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)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Progression-Free Survival (PFS) Measured by RECIST
Time frame: Up to 12 months
Progression-Free Survival (PFS) Measured by iRECIST
Time frame: Up to 12 months
Overall Response Rate (ORR) Measured by RECIST
Time frame: Up to 12 months
Overall Response Rate (ORR) Measured by iRECIST
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 2 years
Clinical Benefit Rate (CBR) Measured by RECIST
Time frame: Up to 12 months
Clinical Benefit Rate (CBR) Measured by iRECIST
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Hosein, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seneca Valley Virus-001 (SVV-001), Nivolumab and Ipilimumab in people with Neuroendocrine Carcinoma and Neuroendocrine Tumors, run by Peter Hosein, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hosein, MD (+1 (305) 2438173, nxr518@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.