Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02664181
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2016-01-22
Brief Title:
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC PRECISE Trial
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Evaluation of Nivolumab an Immune Checkpoint Inhibitor Alone or in Combination With Oral DecitabineTetrahydrouridine as Second Line Therapy for Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-08
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:
PRECISE
Brief Summary:
The purpose of this study is to assess whether treatment with the study drug tetrahydrouridine-decitabine THU-Dec in combination with nivolumab is more effective than treatment with nivolumab alone in patients with NSCLC
Decitabine is an investigational experimental drug that works by depleting DNA methyltransferase 1 DNMT1 DNMT1 is an enzyme or protein that causes chemical changes often increased in cancer Blocking DNMT1 has been shown to reduce tumor formation Decitabine is experimental in this study because it is not approved by the Food and Drug Administration FDA for patients with lung cancer Decitabine is approved by the FDA for treating patients with a blood disease called myelodysplastic syndrome MDS a condition where the bone marrow does not make blood cells normally
THU is an investigational experimental drug that works by blocking an enzyme that breaks down decitabine This enzyme is highly expressed in solid tissues of the body limiting the distribution of decitabine into these tissues including solid cancer tissues So THU will increase the time cells are exposed to decitabine The idea is that THU will also increase the time that the lung cancer cells are exposed to decitabine THU is experimental because it is also not approved by the FDA although it has been extensively used in clinical trials including several cancer trials
Decitabine is an investigational experimental drug that works by depleting DNA methyltransferase 1 DNMT1 DNMT1 is an enzyme or protein that causes chemical changes often increased in cancer Blocking DNMT1 has been shown to reduce tumor formation Decitabine is experimental in this study because it is not approved by the Food and Drug Administration FDA for patients with lung cancer Decitabine is approved by the FDA for treating patients with a blood disease called myelodysplastic syndrome MDS a condition where the bone marrow does not make blood cells normally
THU is an investigational experimental drug that works by blocking an enzyme that breaks down decitabine This enzyme is highly expressed in solid tissues of the body limiting the distribution of decitabine into these tissues including solid cancer tissues So THU will increase the time cells are exposed to decitabine The idea is that THU will also increase the time that the lung cancer cells are exposed to decitabine THU is experimental because it is also not approved by the FDA although it has been extensively used in clinical trials including several cancer trials
Detailed Description:
Primary objective To determine if non-cytotoxic oral THU-Dec when combined with nivolumab can improve objective response rates of nivolumab
Secondary objectives
i To evaluate clinical efficacy end points and toxicity of oral THU-Dec when combined with nivolumab ii evaluate the induction of a T-cell response in patients with metastatic NSCLC iii To evaluate hypotheses regarding mechanisms of resistance and predictive biomarkers for response to nivolumab
Study design This is a Phase 2 randomized two arm trial of nivolumab alone or in combination with THU-Dec in previously treated patients with stage IV Non-Small Cell Lung Cancer NSCLC The primary goal of this trial is to compare the efficacy of oral THU-Dec as a way of enhancing the anti-tumor immune response to nivolumab to that of nivolumab alone The primary efficacy endpoint is overall RECIST-defined response To accomplish this goal 60 patients will be randomized 21 to THU-Dec plus nivolumab or nivolumab only respectively
Secondary objectives
i To evaluate clinical efficacy end points and toxicity of oral THU-Dec when combined with nivolumab ii evaluate the induction of a T-cell response in patients with metastatic NSCLC iii To evaluate hypotheses regarding mechanisms of resistance and predictive biomarkers for response to nivolumab
Study design This is a Phase 2 randomized two arm trial of nivolumab alone or in combination with THU-Dec in previously treated patients with stage IV Non-Small Cell Lung Cancer NSCLC The primary goal of this trial is to compare the efficacy of oral THU-Dec as a way of enhancing the anti-tumor immune response to nivolumab to that of nivolumab alone The primary efficacy endpoint is overall RECIST-defined response To accomplish this goal 60 patients will be randomized 21 to THU-Dec plus nivolumab or nivolumab only respectively
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