NCT03990493

Intratumoral Injection of PV-001-DV Plus DC 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 evaluate the safety of PV-001-DC (autologous monocyte-derived dendritic cells pulsed with tumor lysate) when given in combination with PV-001-DV (Dengue Virus-1 strain #45AZ5) at the dose levels that were identified in the prior 2 arms and to determine if the combination can treat advanced melanoma. Patients will have a prescribed amount of PV-001-DV injected into one of their melanoma tumors. Patients will go to the clinic and have a needle placed in a vein. The PV-001-DC product will be infused into the patient's vein. Approximately every 3 weeks, for a total of 4 treatments, patients will receive additional infusions of PV-001-DC Patients will be at the clinic for at least 1 hour following the end of each PV-001-DC infusion and if they feel fine, they may go home. Approximately 49 days after the first infusion, patients will have a scan to see if their tumors have changed in size. Other scans may be performed during the study at different times. 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 (1 injection)
BIOLOGICAL	Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)	IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2019-06-19
• Last updated: 2023-07-06

Regulatory

• FDA-regulated drug study