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Advanced MelanomaPhase 1NCT03990493

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

A Phase 1 study testing Dengue Virus-1 #45AZ5 (PV-001-DV) and Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC) in people with Advanced Melanoma, run by PrimeVax Immuno-Oncology Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Dengue Virus-1 #45AZ5 (PV-001-DV) and Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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]).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

No sites are listed yet.

Bruce W Lyday contact

(714) 585-7485

bruce.lyday@primevax.com

About this study

Official title: 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

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.

Being tested
Dengue Virus-1 #45AZ5 (PV-001-DV), Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Intratumoral injection of PV-001-DV (1 injection)

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

    IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)

Study groups in NCT03990493
Study groupRoleWhat they receive
PV-001-DV in Combination with PV-001-DCExperimentalIntratumoral injection of PV-001-DV (1 injection) and IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)
Receives: Biological: Dengue Virus-1 #45AZ5 (PV-001-DV); Biological: Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Treatment-Emergent Adverse Events

    Treatment-Emergent Adverse Event Incidence of patients receiving intratumoral injection of PV-001-DV in combination with IV infusion of PV-001-DC

    Measured: 365 days

Secondary outcomes (3)

  1. Overall Response Rate (ORR)

    Tumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST

    Measured: 365 days

  2. Progression-Free Survival (PFS)

    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

    Measured: 365 days

  3. Overall Survival (OS)

    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

    Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment with Dose Modification
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990493
Sponsor's protocol ID
PV001-001 (Arm 3)
Status last verified
Jul 2023
First submitted
12 Jun 2019
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dengue Virus-1 #45AZ5 (PV-001-DV) and Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC) in people with Advanced Melanoma, run by PrimeVax Immuno-Oncology Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bruce W Lyday ((714) 585-7485, bruce.lyday@primevax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Treatment-Emergent Adverse Events (time frame: 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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