Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03803397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-06
First Post:
2018-12-31
Brief Title:
Arm 1 Lysate Pulsed Dendritic Cells PV-001-DC in Patients With Melanoma
Sponsor:
PrimeVax Immuno-Oncology Inc
Organization:
PrimeVax Immuno-Oncology Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-1PD-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-1PD-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 patients 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
Eligible patients must be progressing after having completed prior therapy with a PD-1PD-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-1PD-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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None