14
Participants
Start Date
March 15, 2018
Primary Completion Date
March 23, 2022
Study Completion Date
May 16, 2022
Nivolumab
Nivolumab (BMS-936558) is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. Induction Immunotherapy Phase (4 x 21 days cycles): Nivolumab on Day 1 of each cycle for 4 cycles. Maintenance Immunotherapy beginning on Day 1 of Cycle 5: Nivolumab only on Day 1 of every 4 week period. Participants will continue to receive Nivolumab only on Day 1 of each additional 4 week period that they take part until their 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.
Ipilimumab
Ipilimumab is an antibody (a type of human protein) that is approved to treat patients with metastatic melanoma. In this study, the use of ipilimumab is investigational. Induction Immunotherapy Phase (4 x 21 days cycles): Ipilimumab on Day 1 of each cycle for 4 cycles. 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.
Dendritic Cell based p53 Vaccine
Dendritic Cell based p53 Vaccine (Ad.p53-DC). 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 participant's 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). Induction Immunotherapy Phase (4 x 21 day cycles): Participants will receive the p53 vaccine on Days 1 and 15 of cycle 1 and then again on Day 8 of Cycle 2. Maintenance Immunotherapy beginning on Day 1 of Cycle 5: p53 vaccine three additional times (every 4 weeks over a 12 week period).
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Collaborators (2)
Bristol-Myers Squibb
INDUSTRY
MultiVir, Inc.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER