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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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 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 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.
University of Miami
Miami, Florida, United States
RECRUITINGMaximum 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 12 months
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