Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 120 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• INCLUSION CRITERIA:
• Participants with history of germline BRCA1-Associated Protein-1 (BAP1) mutations.
• Histologically confirmed by NCI LP subclinical, early-stage (Tx-T1) mesotheliomas.
• Participants with other early-stage BAP1-associated malignancies in addition to subclinical, early-stage mesotheliomas are eligible for study.
• The extent of the disease (Tx by radiographic imaging) must be insufficient to warrant approved front-line therapies (surgery, chemotherapy, immunotherapy) per standard of care (SOC). Participants with cT1 tumors may be eligible for study if they have been offered and have refused front-line SOC treatment.
• Age >= 18 years.
• Evaluable disease as confirmed by minimally invasive (videoscopic) assessment (thoracoscopy and/or laparoscopy) performed at screening (within 8 weeks prior to treatment initiation).
• Willingness to undergo pre- and post-treatment minimally invasive thoracoscopy and/or laparoscopy to assess treatment response.
• Willingness to co-enroll on 20C0106 (Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients with BAP1 Tumor Predisposition Syndrome) and/or 06C0014 (Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies) to enable collection/processing of tumor, blood and normal pleura if applicable per PI.
• ECOG performance status 0 - 1
• Adequate pulmonary reserve evidenced by FEV1 and DLCO >= 35% predicted on screening pulmonary function testing (PFTs).
• Oxygen saturation >= 92% on room air by pulse oximetry at screening.
• Adequate renal, hepatic, and hematopoietic function at screening as defined below:
• leukocytes >= 3,000/microL
• absolute neutrophil count >= 1,500/microL (without transfusion or cytokine support within 2 months prior to study treatment initiation)
• absolute lymphocyte count > 800/microL
• platelets >=100,000/microL and < 1,200,000/microL
• prothrombin time (PT) <=2 seconds above the upper limit of normal (ULN)
• total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin <= 1 ULN for participants with total bilirubin > 1.5 ULN
• serum albumin >= 2.0 mg/dL
• aspartate aminotransferase (AST) / alanine aminotransferase (ALT) <= 2.5 X institutional ULN
• creatinine <= 1.6 mg/ml OR creatinine clearance (eGFR) >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
• Individuals of child-bearing potential (IOCBP) and those that can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) from the study entry and up to 6 months (IOCBP) or 3 months (those that can father children) after the last dose of the decitabine/cedazuridine.
• Nursing (including breastfeeding) participants must be willing to discontinue nursing from study treatment initiation through 2 weeks after the last dose of the study drug.
• The ability of a participant to understand and the willingness to sign a written informed consent document.

You cannot join if

• Participants with cancers requiring frontline standard of care treatment.
• Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to study treatment initiation), myocardial infarction (< 6 months prior to study treatment initiation), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II, serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism.
• Therapeutic anticoagulation within 2 weeks prior to study treatment initiation.
• Active Hepatitis A (HAV), Hepatitis B (HBV) (e.g., HBsAg reactive), or Hepatitis C (HCV) (e.g., HCV RNA [qualitative] is detected) at screening.
• History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness.
• Other active infections requiring systemic therapy.
• Active COVID infection.
• Major surgery within 4 weeks prior to study treatment initiation.
• Immunosuppressive medications within 4 weeks prior to study treatment initiation except non-systemic corticosteroids.
• History of prior treatment with a DNA demethylating agent.
• Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in IOCBP at screening).
• Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

decitabine and cedazuridine. An orally available fixed-dose combination agent containing cedazuridine, a cytidine deaminase (CDA) inhibitor, and the cytidine antimetabolite decitabine, with potential antineoplastic activity. Upon oral administration of tdecitabine and cedazuridine, cedazuridine binds to and inhibits CDA, an enzyme primarily found in the gastrointestinal (GI) tract and liver that catalyzes the deamination of cytidine and cytidine analogs. This prevents the breakdown of decitabine, increases its bioavailability and efficacy while decreasing GI toxicity due to the administration of lower doses of decitabine. Decitabine exerts its antineoplastic activity through the incorporation of its triphosphate form into DNA, which inhibits DNA methyltransferase and results in hypomethylation of DNA. This interferes with DNA replication and decreases tumor cell growth. NCI Drug Dictionary

Treatments listed in the registry

• Decitabine/cedazuridine (Drug): Decitabine/cedazuridine (INQOVI) oral tablet (35 mg decitabine and 100 mg cedazuridine) taken 3 consecutive days during the first week of every cycle (1 cycle=28-days) for 6 cycles (i.e., 1 course). Additional 6 cycles (i.e., Course 2) for subjects with stable disease or disease regression. Max (total) of 2 treatment courses.

Non Randomized · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• surgery: Part of the study plan

Main goals

• To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 CPDS following decitabine/cedazuridine treatment (baseline, before each cycle, after every 6 treatment cycles (Course 1 and Course 2), and at the safety visit)

Other goals

• To evaluate the safety of decitabine/cedazuridine
• To determine PFS in participants receiving decitabine/cedazuridine

Planned enrollment: 15 (estimated).

• National Institutes of Health Clinical Center, Bethesda, Maryland

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05960773
• NCI Drug Dictionary: C115102

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 15, 2026. Public record; not medical advice.