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New treatment option for Neuroendocrine Carcinoma
Official title SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
ClinicalTrials.gov ID: NCT06889493
What this study is testing
What is Seneca Valley Virus-001 (SVV-001)?
Seneca Valley Virus-001 (SVV-001) is an investigational medicine, being studied as a potential treatment for neuroendocrine carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor...
You likely can't join if
- Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such...
- 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...
- Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of...
- 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...
- Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the...
- Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.