Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03406715
Status:
TERMINATED
Last Update Posted:
2023-03-30
First Post:
2018-01-16
Brief Title:
Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer SCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Combination Immunotherapy With Ipilimumab and Nivolumab Plus a Dendritic Cell Based p53 Vaccine Adp53-DC in Patients With Relapsed Small Cell Lung Cancer SCLC
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor closed study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out what effects good and bad immunotherapy treatment using the p53 vaccine Adp53-DC in combination with Nivolumab and Ipilimumab has on small cell lung cancer Immunotherapy is a cancer therapy that uses the bodys immune system to fight cancer cells
This study can be divided into three different phases initial Induction Immunotherapy Maintenance Immunotherapy and Retreatment
This study can be divided into three different phases initial Induction Immunotherapy Maintenance Immunotherapy and Retreatment
Detailed Description:
During the Induction Immunotherapy phase 4 x 21 day cycles of the study participants will receive Ipilimumab and Nivolumab on Day 1 of each cycle for 4 cycles Participants will receive the p53 vaccine on Days 1 and 15 of cycle 1 and then again on Day 8 of Cycle 2
Beginning on Day 1 of Cycle 5 participants will start Maintenance Immunotherapy During this phase of the study participants will receive Nivolumab only on Day 1 of every 4 week period Participants will also receive the p53 vaccine three additional times every 4 weeks over a 12 week period During Maintenance Immunotherapy you will continue to receive Nivolumab only on Day 1 of each additional 4 week period that you take part until your disease progresses
The Retreatment phase of the study may be available to participants whose doctor feels they would benefit from retreatment and if they qualify for this retreatment During retreatment participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year
P53 Vaccine production
The p53 vaccine will be made by inserting the p53 gene a gene is a hereditary unit of all living organism within a cell into a subset of the participants own white blood cells The insertion of the gene into their white blood cells will occur in the laboratory after their cells have been extracted from their body through a procedure called leukopheresis similar to dialysis
Beginning on Day 1 of Cycle 5 participants will start Maintenance Immunotherapy During this phase of the study participants will receive Nivolumab only on Day 1 of every 4 week period Participants will also receive the p53 vaccine three additional times every 4 weeks over a 12 week period During Maintenance Immunotherapy you will continue to receive Nivolumab only on Day 1 of each additional 4 week period that you take part until your disease progresses
The Retreatment phase of the study may be available to participants whose doctor feels they would benefit from retreatment and if they qualify for this retreatment During retreatment participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year
P53 Vaccine production
The p53 vaccine will be made by inserting the p53 gene a gene is a hereditary unit of all living organism within a cell into a subset of the participants own white blood cells The insertion of the gene into their white blood cells will occur in the laboratory after their cells have been extracted from their body through a procedure called leukopheresis similar to dialysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MVIR-Adp53DC-001 | OTHER | MultiVir Inc Protocol Number | None |
| CA209-9KN | OTHER | None | None |