{"id":399174,"date":"2024-03-31T19:00:00","date_gmt":"2024-04-01T00:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/?post_type=platowire&p=399174"},"modified":"2024-03-31T19:00:00","modified_gmt":"2024-04-01T00:00:00","slug":"intratumoral-injection-of-pv-001-dv-plus-dc-in-patients-with-melanoma","status":"publish","type":"platowire","link":"https:\/\/platohealth.ai\/platowire\/intratumoral-injection-of-pv-001-dv-plus-dc-in-patients-with-melanoma\/","title":{"rendered":"Intratumoral Injection of PV-001-DV Plus DC in Patients With Melanoma"},"content":{"rendered":"
\n

Studies<\/h3>\n\n\n\n\n\n\n\n\n\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Conditions<\/h3>\n

Study First Submitted Date<\/td>\n2019-06-12<\/td>\n<\/tr>\n
Study First Posted Date <\/td>\n2019-06-19<\/td>\n<\/tr>\n
Last Update Posted Date<\/td>\n2023-07-06<\/td>\n<\/tr>\n
Start Month Year<\/td>\nApril 1, 2024<\/td>\n<\/tr>\n
Primary Completion Month Year<\/td>\nSeptember 30, 2024<\/td>\n<\/tr>\n
Verification Month Year<\/td>\nJuly 2023<\/td>\n<\/tr>\n
Verification Date<\/td>\n2023-07-31<\/td>\n<\/tr>\n
Last Update Posted Date<\/td>\n2023-07-06<\/td>\n<\/tr>\n
\n\n\n\n
Sequence:<\/td>\n52145637<\/td>\n<\/tr>\n
Name<\/td>\nAdvanced Melanoma<\/td>\n<\/tr>\n
Downcase Name<\/td>\nadvanced melanoma<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Id Information<\/h3>\n\n\n\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Design Groups<\/h3>\n

Sequence:<\/td>\n40139889<\/td>\n<\/tr>\n
Id Source<\/td>\norg_study_id<\/td>\n<\/tr>\n
Id Value<\/td>\nPV001-001 (Arm 3)<\/td>\n<\/tr>\n
\n\n\n\n\n
Sequence:<\/td>\n55566535<\/td>\n<\/tr>\n
Group Type<\/td>\nExperimental<\/td>\n<\/tr>\n
Title<\/td>\nPV-001-DV in Combination with PV-001-DC<\/td>\n<\/tr>\n
Description<\/td>\nIntratumoral injection of PV-001-DV (1 injection) and IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Interventions<\/h3>\n\n\n\n\n\n
Sequence:<\/td>\n52461489<\/td>\nSequence:<\/td>\n52461490<\/td>\n<\/tr>\n
Intervention Type<\/td>\nBiological<\/td>\nIntervention Type<\/td>\nBiological<\/td>\n<\/tr>\n
Name<\/td>\nDengue Virus-1 #45AZ5 (PV-001-DV)<\/td>\nName<\/td>\nAutologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)<\/td>\n<\/tr>\n
Description<\/td>\nIntratumoral injection of PV-001-DV (1 injection)<\/td>\nDescription<\/td>\nIV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Design Outcomes<\/h3>\n\n\n\n\n\n\n<\/tr>\n\n
Sequence:<\/td>\n177291419<\/td>\nSequence:<\/td>\n177291420<\/td>\nSequence:<\/td>\n177291421<\/td>\nSequence:<\/td>\n177291422<\/td>\n<\/tr>\n
Outcome Type<\/td>\nprimary<\/td>\nOutcome Type<\/td>\nsecondary<\/td>\nOutcome Type<\/td>\nsecondary<\/td>\nOutcome Type<\/td>\nsecondary<\/td>\n<\/tr>\n
Measure<\/td>\nIncidence and severity of Treatment-Emergent Adverse Events<\/td>\nMeasure<\/td>\nOverall Response Rate (ORR)<\/td>\nMeasure<\/td>\nProgression-Free Survival (PFS)<\/td>\nMeasure<\/td>\nOverall Survival (OS)<\/td>\n<\/tr>\n
Time Frame<\/td>\n365 days<\/td>\nTime Frame<\/td>\n365 days<\/td>\nTime Frame<\/td>\n365 days<\/td>\nTime Frame<\/td>\n365 days<\/td>\n<\/tr>\n
Description<\/td>\nTreatment-Emergent Adverse Event Incidence of patients receiving intratumoral injection of PV-001-DV in combination with IV infusion of PV-001-DC<\/td>\nDescription<\/td>\nTumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST<\/td>\nDescription<\/td>\nThe 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<\/td>\nDescription<\/td>\nOverall 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<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Browse Conditions<\/h3>\n\n\n\n\n\n
Sequence:<\/td>\n193391637<\/td>\nSequence:<\/td>\n193391632<\/td>\nSequence:<\/td>\n193391633<\/td>\nSequence:<\/td>\n193391634<\/td>\nSequence:<\/td>\n193391635<\/td>\nSequence:<\/td>\n193391636<\/td>\nSequence:<\/td>\n193391638<\/td>\nSequence:<\/td>\n193391639<\/td>\n<\/tr>\n
Mesh Term<\/td>\nNeoplasms<\/td>\nMesh Term<\/td>\nMelanoma<\/td>\nMesh Term<\/td>\nNeuroendocrine Tumors<\/td>\nMesh Term<\/td>\nNeuroectodermal Tumors<\/td>\nMesh Term<\/td>\nNeoplasms, Germ Cell and Embryonal<\/td>\nMesh Term<\/td>\nNeoplasms by Histologic Type<\/td>\nMesh Term<\/td>\nNeoplasms, Nerve Tissue<\/td>\nMesh Term<\/td>\nNevi and Melanomas<\/td>\n<\/tr>\n
Downcase Mesh Term<\/td>\nneoplasms<\/td>\nDowncase Mesh Term<\/td>\nmelanoma<\/td>\nDowncase Mesh Term<\/td>\nneuroendocrine tumors<\/td>\nDowncase Mesh Term<\/td>\nneuroectodermal tumors<\/td>\nDowncase Mesh Term<\/td>\nneoplasms, germ cell and embryonal<\/td>\nDowncase Mesh Term<\/td>\nneoplasms by histologic type<\/td>\nDowncase Mesh Term<\/td>\nneoplasms, nerve tissue<\/td>\nDowncase Mesh Term<\/td>\nnevi and melanomas<\/td>\n<\/tr>\n
Mesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-list<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\nMesh Type<\/td>\nmesh-ancestor<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Sponsors<\/h3>\n\n\n\n\n\n
Sequence:<\/td>\n48296592<\/td>\nSequence:<\/td>\n48296593<\/td>\n<\/tr>\n
Agency Class<\/td>\nINDUSTRY<\/td>\nAgency Class<\/td>\nFED<\/td>\n<\/tr>\n
Lead Or Collaborator<\/td>\nlead<\/td>\nLead Or Collaborator<\/td>\ncollaborator<\/td>\n<\/tr>\n
Name<\/td>\nPrimeVax Immuno-Oncology Inc.<\/td>\nName<\/td>\nWalter Reed Army Institute of Research (WRAIR)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Central Contacts<\/h3>\n\n\n\n\n\n\n\n<\/tr>\n\n
Sequence:<\/td>\n12002701<\/td>\n<\/tr>\n
Contact Type<\/td>\nprimary<\/td>\n<\/tr>\n
Name<\/td>\nBruce W Lyday<\/td>\n<\/tr>\n
Phone<\/td>\n(714) 585-7485<\/td>\n<\/tr>\n
Email<\/td>\nbruce.lyday@primevax.com<\/td>\n<\/tr>\n
Role<\/td>\nContact<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Design Group Interventions<\/h3>\n\n\n\n\n
Sequence:<\/td>\n68116655<\/td>\nSequence:<\/td>\n68116656<\/td>\n<\/tr>\n
Design Group Id<\/td>\n55566535<\/td>\nDesign Group Id<\/td>\n55566535<\/td>\n<\/tr>\n
Intervention Id<\/td>\n52461489<\/td>\nIntervention Id<\/td>\n52461490<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Eligibilities<\/h3>\n\n\n\n<\/tr>\n\n\n\n\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n\n\n
Sequence:<\/td>\n30751377<\/td>\n<\/tr>\n
Gender<\/td>\nAll<\/td>\n<\/tr>\n
Minimum Age<\/td>\n18 Years<\/td>\n<\/tr>\n
Maximum Age<\/td>\nN\/A<\/td>\n<\/tr>\n
Healthy Volunteers<\/td>\nNo<\/td>\n<\/tr>\n
Criteria<\/td>\nInclusion Criteria:<\/p>\n

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
\nPatients 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
\nPatients must be progressing after having completed one standard of care therapy for metastatic melanoma
\nTumor specimens must be available for tumor lysates and immunological studies.
\nTumors must be available for intratumoral injection of dengue virus. This includes cutaneous and subcutaneous lesions with ultrasound-guided injection.
\nEastern Cooperative Oncology Group (ECOG), Performance Status of \u2264 2 (corresponds to a Karnofsky Performance Status (KPS) of \u2265 70).
\nPatients must be 18 years or older and able to give informed consent.
\nAdequate bone marrow function of White Blood Cell (WBC) count to \u2265 1,500\/microliter (uL); platelet count \u2265 100,000\/mm3; absolute neutrophil count (ANC) > 1,500\/mm3
\nPatients must have adequate renal function by serum creatinine of \u2264 2.0 milligrams\/decaliter (mg\/dL).
\nAdequate hepatic function of bilirubin \u2264 2.5 mg\/dL; Serum Glutamic Oxaloacetic acid Transaminase\/ Serum Glutamic Pyruvic Transaminase (SGOT\/SGPT) < 3\u00d7 upper limit of normal (ULN).
\nPatients must have the required wash out periods from prior therapy:
\nTopical therapy: 2 weeks.
\nChemotherapy and radiotherapy: 4 weeks.
\nOther investigational therapy: 4 weeks
\nPatients 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.
\nWomen of reproductive potential must have a negative urine pregnancy test.
\nPatients should have a life expectancy of > 4 months.
\nPatient should be able to comply with the treatment schedule and have the ability to understand and the willingness to sign the informed consent document.
\nPatients 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]).<\/p>\n

Exclusion Criteria:<\/p>\n

Patients with positive antibody to any Dengue Virus serotype by tetravalent ELISA assay.
\nPatients with prior vaccinations or positive Ab detected by ELISA to: West Nile, St. Louis Encephalitis, or Yellow Fever
\nPre-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.
\nKnown 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.
\nPatients on immunosuppressive therapy. Concurrent steroid use of not more than an equivalent of 10 mg of prednisone is allowed.
\nAny other open wounds.
\nPrevious organ transplantation.
\nPatients 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).
\nPatients with White Blood Cell count <1,500\/uL; platelet count <100,000\/mm3; absolute neutrophil count (ANC) 1,500\/mm3 (Grade 2)
\nPatients with inadequate renal function by serum creatinine of >1.5 x ULN (Grade 2)
\nPatients with inadequate liver function by SGPT\/SGOT > 3x ULN, and bilirubin >2.5 mg\/dl (Grade 2)
\nPatients with active infection or with a fever >101\u00b0F (38.5\u00b0C) within 3 days prior to the first scheduled treatment.
\nConcurrent participation in other treatment related clinical studies. Non-treatment studies (e.g. observation or tumor cell analysis studies) are allowed.
\nPrior 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.
\nSignificant 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).
\nFemale patients who are pregnant or lactating.
\nPatients taken off Checkpoint Blockade agents: Ipilimumab, Nivolumab, Pembrolizumab, for Grade 3 or greater autoimmune toxicity. [7]
\nPatients who are positive for B-RafV600 mutation and are responding to targeted therapy.
\nAny 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.
\nPatients with endocrinopathy greater than grade III.
\nPatients 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.
\nPrior history or serologic evidence of other flavivirus infections (yellow fever, St. Louis encephalitis, West Nile virus)
\nPrior history of having received a flavivirus vaccine
\nPatients who are actively taking Non Steroid Anti Inflammatory Drugs (NSAID) including aspirin<\/td>\n<\/tr>\n

Adult<\/td>\nTrue<\/td>\n<\/tr>\n
Child<\/td>\nFalse<\/td>\n<\/tr>\n
Older Adult<\/td>\nTrue<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Calculated Values<\/h3>\n\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n\n\n<\/tr>\n\n\n<\/tr>\n\n\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Designs<\/h3>\n

Sequence:<\/td>\n254161828<\/td>\n<\/tr>\n
Registered In Calendar Year<\/td>\n2019<\/td>\n<\/tr>\n
Were Results Reported<\/td>\nFalse<\/td>\n<\/tr>\n
Has Single Facility<\/td>\nFalse<\/td>\n<\/tr>\n
Minimum Age Num<\/td>\n18<\/td>\n<\/tr>\n
Minimum Age Unit<\/td>\nYears<\/td>\n<\/tr>\n
Number Of Primary Outcomes To Measure<\/td>\n1<\/td>\n<\/tr>\n
Number Of Secondary Outcomes To Measure<\/td>\n3<\/td>\n<\/tr>\n
\n\n\n\n\n\n\n\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Responsible Parties<\/h3>\n

Sequence:<\/td>\n30497650<\/td>\n<\/tr>\n
Allocation<\/td>\nN\/A<\/td>\n<\/tr>\n
Intervention Model<\/td>\nSingle Group Assignment<\/td>\n<\/tr>\n
Observational Model<\/td>\n<\/td>\n<\/tr>\n
Primary Purpose<\/td>\nTreatment<\/td>\n<\/tr>\n
Time Perspective<\/td>\n<\/td>\n<\/tr>\n
Masking<\/td>\nNone (Open Label)<\/td>\n<\/tr>\n
Intervention Model Description<\/td>\nSingle Group Assignment with Dose Modification<\/td>\n<\/tr>\n
\n\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Studies 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 Conditions Sequence: 52145637 Name Advanced Melanoma Downcase Name advanced melanoma Id Information Sequence: […]<\/p>\n","protected":false},"author":2,"featured_media":324,"menu_order":0,"template":"Default","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"aiwire-tag":[64,65,58,63,60,61,62,59],"aiwire":[17],"acf":[],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/399174"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/platowire"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/399174\/revisions"}],"predecessor-version":[{"id":566735,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/399174\/revisions\/566735"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/324"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=399174"}],"wp:term":[{"taxonomy":"aiwire-tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/aiwire-tag?post=399174"},{"taxonomy":"aiwire","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/aiwire?post=399174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Sequence:<\/td>\n28863924<\/td>\n<\/tr>\n
Responsible Party Type<\/td>\nSponsor<\/td>\n<\/tr>\n