Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT02664181
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given at 3mg/kg by IV every two weeks until progression
  • oral decitabine — DRUG
    oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
  • Tetrahydrouridine — DRUG
    Oral THU \~10 mg/kg twice weekly on consecutive days

Study Details

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.

Key Dates

Start date
Jun 6, 2017
Status verified
Aug 2024
Primary completion
Jul 2, 2019
Completion
May 19, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral THU/decitabine + Nivolumab
    Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
  • Active Comparator: Nivolumab
    Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.

Primary Outcome Measure

Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST1.1) [ Time Frame: Up to 52 weeks after beginning therapy ]

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Cancer ResearchBethesdaMaryland20892-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44118-

Find similar trials in Bethesda, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Center for Cancer Research· Bethesda, MDCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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