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NCT02664181 · ClinicalTrials.gov registry record · Phase 2
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02664181 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants.
The verdict
NCT02664181, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nivolumab
- DRUG Tetrahydrouridine
- DRUG oral decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2024-05-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02664181
The ClinicalTrials.gov registry entry for NCT02664181 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT02664181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02664181 about?
NCT02664181 is a clinical study titled "Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial". 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 depletin...
What is the current status of trial NCT02664181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-06-06. Estimated completion is 2024-05-19.
What interventions are being tested in trial NCT02664181?
The interventions under investigation include: Nivolumab (DRUG), Tetrahydrouridine (DRUG), oral decitabine (DRUG).
Who is sponsoring clinical trial NCT02664181?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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