Arm 1: Infusion of Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC) in Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT03803397|
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : September 12, 2019
Autologous monocyte-derived dendritic cells pulsed with tumor lysate (PV-001-DC) will be given to a group of 3 people. If this is found to be safe, it will be given to up to 7 other people, for a total of up to 10 people in this arm. This will be the first study of PV-001-DC.
Eligible patients must be progressing after having completed prior therapy with a PD-1/PD-L1 antagonist alone or in combination with anti-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 CTLA-4 for metastatic melanoma.
Although other kinds of dendritic cells (DCs) have been approved to treat some forms of cancer, they have not been approved to treat melanoma. PV-001-DC is a special kind of DCs that is combined with tumor lysate. The study procedures will start with the removal of a small amount of tumor tissue processed into protein fragments (lysate). There will also be collection of white blood cells through apheresis (a procedure in which blood is drawn from a patient and separated into its different cell types), the white blood cells will be collected and the remainder returned to the patient. Dendritic cells will be grown from the collected white blood cells and combined with the lysate to form PV-001-DC.
On the first day of study treatment, 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 the PV-001-DC infusion and if they feel fine, they may go home.
Scans will be performed during the study at different times to see if their tumors have changed in size. 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.
Investigators will monitor patients carefully for any harmful side effects. The side effects in people cannot be completely known ahead of time
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Biological: PV-001-DC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Efficacy of Intratumoral Injection of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: PV-001-DC alone
Autologous Monocyte-derived Lysate Pulsed Dendritic Cells
Patient-specific cellular therapeutic for cancer immunotherapy
- Incidence and severity of Treatment-Emergent Adverse Events [ Time Frame: 365 days ]Treatment-Emergent Adverse Event Incidence in patients receiving 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