NCT03989895

Intratumoral Injection of Dengue Virus-1 #45AZ5 (PV-001-DV) in Patients With Melanoma

A Study to Evaluate the Safety and Efficacy of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PrimeVax Immuno-Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this arm of the study is to find the best way to give patients this investigational product and determine if it can treat advanced melanoma by stimulating the immune system. PV-001-DV is an attenuated (weakened) strain of dengue virus developed as a potential preventative vaccine for dengue fever by the US Army as Dengue Virus-1 #45AZ5. This is the first time PV-001-DV will be given to patients with melanoma. Up to 4 dose levels of PV-001-DV will tested in this arm. PV-001-DV (at the lowest dose) will be given to a group of 3 people. As each dose level is found to be safe, it will be given to another other 3 people at the next higher dose level, for a total of up to 10 people in this study. Investigators will monitor patients carefully for any harmful side effects. The side effects in people cannot be completely known ahead of time. Patients must be progressing after having completed prior therapy with a PD-1 / PD-L1 antagonist alone or in combination with anti-CTLA-4. If the patient is positive for BRAF, the patient must have progressed on at least one BRAF inhibitor in addition to a PD-1 / PD-L1 inhibitor alone or in combination with CTLA-4 for metastatic melanoma. Patients will have a prescribed amount of PV-001-DV injected into one of their melanoma tumors. Scans will be performed during the study at different times to see if their tumors have changed in size. Patients will also have their blood and small samples of tumors tested for changes to the immune system. After 365 days, the trial will be completed for that patient.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Dengue Virus-1 #45AZ5 (PV-001-DV)	Intratumoral injection of PV-001-DV

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2019-06-18
• Last updated: 2023-07-06

Regulatory

• FDA-regulated drug study