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Intratumoral Injection of PV-001-DV Plus DC in Patients With Melanoma

NCT03990493 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-06

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • PrimeVax Immuno-Oncology Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990493 on ClinicalTrials.gov