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UNKNOWNPHASE1

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

NCT03990493•PrimeVax Immuno-Oncology Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Biopsy confirmed patients with un-resectable American Joint Committee on Cancer (AJCC), Stage III or IV melanoma who have measurable disease. Measurable disease is required, and is defined as tumor can be measured in one dimension along the longest diameter
•2. Patients must have tumors that are not responsive having completed prior therapy with a Progressive Death (PD)-1 / PD-Ligand-1 (PDL-1), antagonist alone or in combination with anti-Cytotoxic T Lymphocyte Antigen 4 (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 CTLA4 for metastatic melanoma
•3. Patients must be progressing after having completed one standard of care therapy for metastatic melanoma
•4. Tumor specimens must be available for tumor lysates and immunological studies.
•5. Tumors must be available for intratumoral injection of dengue virus. This includes cutaneous and subcutaneous lesions with ultrasound-guided injection.
•6. Eastern Cooperative Oncology Group (ECOG), Performance Status of ≤ 2 (corresponds to a Karnofsky Performance Status (KPS) of ≥ 70).
•7. Patients must be 18 years or older and able to give informed consent.
•8. Adequate bone marrow function of White Blood Cell (WBC) count to ≥ 1,500/microliter (uL); platelet count ≥ 100,000/mm3; absolute neutrophil count (ANC) \> 1,500/mm3
•9. Patients must have adequate renal function by serum creatinine of ≤ 2.0 milligrams/decaliter (mg/dL).
•10. Adequate hepatic function of bilirubin ≤ 2.5 mg/dL; Serum Glutamic Oxaloacetic acid Transaminase/ Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) \< 3× upper limit of normal (ULN).
+8 more criteria

Exclusion Criteria

•1. Patients with positive antibody to any Dengue Virus serotype by tetravalent ELISA assay.
•2. Patients with prior vaccinations or positive Ab detected by ELISA to: West Nile, St. Louis Encephalitis, or Yellow Fever
•3. Pre-existing autoimmune or antibody mediated disease including systemic lupus erythematous, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
•4. Known history of human immunodeficiency virus (HIV) or any active immunosuppressive systemic infection or a suppressed immune system, including acquired immuno-deficiency syndrome (AIDS) or HIV positivity and known hepatitis B or C infections (HCV or HBC), as assessed by serology.
•5. Patients on immunosuppressive therapy. Concurrent steroid use of not more than an equivalent of 10 mg of prednisone is allowed.
•6. Any other open wounds.
•7. Previous organ transplantation.
•8. Patients with clinically significant dermatological disorders, as judged by the clinical investigator (e.g., eczema or psoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or any history of Darier's disease (Keratosis Follicularis).
•9. Patients with White Blood Cell count \<1,500/uL; platelet count \<100,000/mm3; absolute neutrophil count (ANC) 1,500/mm3 (Grade 2)
•10. Patients with inadequate renal function by serum creatinine of \>1.5 x ULN (Grade 2)
+14 more criteria

Key Dates

Start Date

April 1, 2024

Primary Completion Date

September 30, 2024

Completion Date

December 31, 2024

Last Updated

July 6, 2023

Enrollment

ESTIMATED participants

Conditions

Advanced Melanoma

Interventions

Dengue Virus-1 #45AZ5 (PV-001-DV)

BIOLOGICAL

Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)

BIOLOGICAL

Contacts

Bruce W Lyday

CONTACT

(714) 585-7485 bruce.lyday@primevax.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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