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


Study First Submitted Date 2019-06-12
Study First Posted Date 2019-06-19
Last Update Posted Date 2023-07-06
Start Month Year April 1, 2024
Primary Completion Month Year September 30, 2024
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-06


Sequence: 52145637
Name Advanced Melanoma
Downcase Name advanced melanoma

Id Information

Sequence: 40139889
Id Source org_study_id
Id Value PV001-001 (Arm 3)

Design Groups

Sequence: 55566535
Group Type Experimental
Title PV-001-DV in Combination with PV-001-DC
Description Intratumoral injection of PV-001-DV (1 injection) and IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)


Sequence: 52461489 Sequence: 52461490
Intervention Type Biological Intervention Type Biological
Name Dengue Virus-1 #45AZ5 (PV-001-DV) Name Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)
Description Intratumoral injection of PV-001-DV (1 injection) Description IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)

Design Outcomes

Sequence: 177291419 Sequence: 177291420 Sequence: 177291421 Sequence: 177291422
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Incidence and severity of Treatment-Emergent Adverse Events Measure Overall Response Rate (ORR) Measure Progression-Free Survival (PFS) Measure Overall Survival (OS)
Time Frame 365 days Time Frame 365 days Time Frame 365 days Time Frame 365 days
Description Treatment-Emergent Adverse Event Incidence of patients receiving intratumoral injection of PV-001-DV in combination with IV infusion of PV-001-DC Description Tumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST Description The length of time during the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse, up to the end of the study Description Overall Survival is measured from the date of enrollment to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date, up to the end of the study

Browse Conditions

Sequence: 193391637 Sequence: 193391632 Sequence: 193391633 Sequence: 193391634 Sequence: 193391635 Sequence: 193391636 Sequence: 193391638 Sequence: 193391639
Mesh Term Neoplasms Mesh Term Melanoma Mesh Term Neuroendocrine Tumors Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms, Nerve Tissue Mesh Term Nevi and Melanomas
Downcase Mesh Term neoplasms Downcase Mesh Term melanoma Downcase Mesh Term neuroendocrine tumors Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms, nerve tissue Downcase Mesh Term nevi and melanomas
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48296592 Sequence: 48296593
Agency Class INDUSTRY Agency Class FED
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name PrimeVax Immuno-Oncology Inc. Name Walter Reed Army Institute of Research (WRAIR)

Central Contacts

Sequence: 12002701
Contact Type primary
Name Bruce W Lyday
Phone (714) 585-7485
Role Contact

Design Group Interventions

Sequence: 68116655 Sequence: 68116656
Design Group Id 55566535 Design Group Id 55566535
Intervention Id 52461489 Intervention Id 52461490


Sequence: 30751377
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

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
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
Patients must be progressing after having completed one standard of care therapy for metastatic melanoma
Tumor specimens must be available for tumor lysates and immunological studies.
Tumors must be available for intratumoral injection of dengue virus. This includes cutaneous and subcutaneous lesions with ultrasound-guided injection.
Eastern Cooperative Oncology Group (ECOG), Performance Status of ≤ 2 (corresponds to a Karnofsky Performance Status (KPS) of ≥ 70).
Patients must be 18 years or older and able to give informed consent.
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
Patients must have adequate renal function by serum creatinine of ≤ 2.0 milligrams/decaliter (mg/dL).
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).
Patients must have the required wash out periods from prior therapy:
Topical therapy: 2 weeks.
Chemotherapy and radiotherapy: 4 weeks.
Other investigational therapy: 4 weeks
Patients of reproductive potential and their partners must agree to use an effective (>95% reliability) form of contraception during the study and for 4 weeks following the last study drug. Patients who become pregnant during the course of the study will be withdrawn from the trial.
Women of reproductive potential must have a negative urine pregnancy test.
Patients should have a life expectancy of > 4 months.
Patient should be able to comply with the treatment schedule and have the ability to understand and the willingness to sign the informed consent document.
Patients with manageable Central Nervous System (CNS), metastases may be selected to this trial. CNS metastasis patients are eligible if the CNS metastases have had no progression for at least 4 weeks (as defined by Magnetic Resonance Imaging [MRI]/Computerized Tomography [CT]).

Exclusion Criteria:

Patients with positive antibody to any Dengue Virus serotype by tetravalent ELISA assay.
Patients with prior vaccinations or positive Ab detected by ELISA to: West Nile, St. Louis Encephalitis, or Yellow Fever
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.
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.
Patients on immunosuppressive therapy. Concurrent steroid use of not more than an equivalent of 10 mg of prednisone is allowed.
Any other open wounds.
Previous organ transplantation.
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).
Patients with White Blood Cell count <1,500/uL; platelet count <100,000/mm3; absolute neutrophil count (ANC) 1,500/mm3 (Grade 2)
Patients with inadequate renal function by serum creatinine of >1.5 x ULN (Grade 2)
Patients with inadequate liver function by SGPT/SGOT > 3x ULN, and bilirubin >2.5 mg/dl (Grade 2)
Patients with active infection or with a fever >101°F (38.5°C) within 3 days prior to the first scheduled treatment.
Concurrent participation in other treatment related clinical studies. Non-treatment studies (e.g. observation or tumor cell analysis studies) are allowed.
Prior malignancy (active within 3 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.
Significant cardiovascular disease (i.e., New York Heart Association (NYHA) class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
Female patients who are pregnant or lactating.
Patients taken off Checkpoint Blockade agents: Ipilimumab, Nivolumab, Pembrolizumab, for Grade 3 or greater autoimmune toxicity. [7]
Patients who are positive for B-RafV600 mutation and are responding to targeted therapy.
Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with his/her participation in the study, or to interfere with the interpretation of the results.
Patients with endocrinopathy greater than grade III.
Patients who have undergone a splenectomy in their previous medical history will be excluded from this trial. Evidence of a splenectomy will be from history or records.
Prior history or serologic evidence of other flavivirus infections (yellow fever, St. Louis encephalitis, West Nile virus)
Prior history of having received a flavivirus vaccine
Patients who are actively taking Non Steroid Anti Inflammatory Drugs (NSAID) including aspirin

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254161828
Registered In Calendar Year 2019
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3


Sequence: 30497650
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Single Group Assignment with Dose Modification

Responsible Parties

Sequence: 28863924
Responsible Party Type Sponsor