Sponsor closed study
Combination Immunotherapy With Ipilimumab and Nivolumab Plus a Dendritic Cell Based p53 Vaccine (Ad.p53-DC) in Patients With Relapsed Small Cell Lung Cancer (SCLC)
Sponsor study identifier
Secondary identifiers
OTHER · Bristol-Myers Squibb Protocol Number
OTHER · MultiVir, Inc. Protocol Number
interventional
14
1 country
1
Study Start
March 15, 2018
Actual (reported)Primary Completion
March 23, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)The purpose of this study is to find out what effects (good and bad) immunotherapy treatment using the p53 vaccine (Ad.p53-DC) in combination with Nivolumab and Ipilimumab has on small cell lung cancer. Immunotherapy is a cancer therapy that uses the body's immune system to fight cancer cells. This study can be divided into three different phases: initial Induction Immunotherapy, Maintenance Immunotherapy and Retreatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 16, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2018
Actual (reported)January 23, 2018
Actual (reported)March 15, 2018
Actual (reported)March 23, 2022
Actual (reported)May 16, 2022
Actual (reported)March 30, 2023
Actual (reported)Disease Control Rate (DCR)
Response will be assessed primarily using the response evaluation criteria in solid tumors (RECIST v1.1). The immune related (ir)RECIST will also be used secondarily. DCR = Complete Response (CR) = Partial Response (PR) + Stable Disease (SD) rates. The disease control (DCR=CR+PR+SD) rates will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group.
Up to 3 years
Progression Free Survival (PFS)
Up to 3 years
Overall Survival (OS)
Up to 3 years
Overall Response Rate (ORR)
Up to 3 years
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially 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.
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.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
14 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2018
First Posted
January 23, 2018
Study Start
March 15, 2018
Actual (reported)Primary Completion
Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer
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 (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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
March 23, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)Last Updated
March 30, 2023
Results First Posted
March 30, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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