Arm 3: Intratumoral Injection of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT03990493|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : September 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma||Biological: Dengue Virus-1 #45AZ5 (PV-001-DV) Biological: Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment with Dose Modification|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: PV-001-DV in Combination with PV-001-DC
Intratumoral injection of PV-001-DV (1 injection) and IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)
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)
- Incidence and severity of Treatment-Emergent Adverse Events [ Time Frame: 365 days ]Treatment-Emergent Adverse Event Incidence of patients receiving intratumoral injection of PV-001-DV in combination with IV infusion of PV-001-DC
- Overall Response Rate (ORR) [ Time Frame: 365 days ]Tumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST
- Progression-Free Survival (PFS) [ Time Frame: 365 days ]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
- Overall Survival (OS) [ Time Frame: 365 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990493
|Contact: Bruce W Lyday||(714) email@example.com|