Study on Oral Decitabine/Cedazuridine Combined with Nivolumab for Patients with Mucosal Melanoma

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05089370

Provider View

This clinical trial is exploring a new treatment combination of oral Decitabine/Cedazuridine (DEC-C) and Nivolumab to see if it can improve the immune system's ability to fight mucosal melanoma, a type of skin cancer that occurs in moist surfaces inside the body.

Patient Parameters

Program Overview

The study aims to find out if combining DEC-C with Nivolumab can boost the immune system's response against mucosal melanoma by activating certain immune pathways and increasing the presence of immune cells that attack tumors. This approach may help improve the effectiveness of Nivolumab treatment for patients with this type of cancer.

Description

This study is being conducted at the University of Colorado Cancer Center and involves two phases. In Phase Ib, researchers will determine the best dose of DEC-C to use with Nivolumab by testing different doses on a small group of patients. In Phase II, the study will evaluate how well this combination works and how safe it is for patients. The goal is to see if this treatment can improve the response rate in patients with mucosal melanoma compared to standard treatments. The study will involve up to 21 patients, and researchers hope to see a significant improvement in treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to sign a consent form and follow study procedures.
  • Men and women aged 18 to 100.
  • Diagnosed with advanced mucosal melanoma that cannot be removed by surgery.
  • May have had previous treatments with certain immune therapies.
  • Must have measurable cancer that can be tracked by scans or exams.
  • Previously treated brain metastases are allowed if stable.
  • Must be in good general health with adequate blood, liver, and kidney function.
  • HIV-positive patients are eligible if their condition is stable.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must agree to provide tumor samples for research if available.
  • Must agree to have biopsies done before and during the study, unless not possible or safe.

Exclusion Criteria

  • Cannot have other active cancers, except for certain treated or stable types.
  • Cannot be on certain medications that affect the study drug.
  • Cannot have had recent chemotherapy or certain other treatments.
  • Cannot have active brain or spinal cord disease.
  • Cannot be on high doses of steroids or have active infections like Hepatitis B or C.
  • Cannot have active autoimmune diseases requiring treatment.
  • Cannot have a history of lung inflammation requiring steroids.
  • Cannot have received live vaccines recently.
  • Cannot have conditions that interfere with the study or are not in the patient's best interest.
  • Cannot be pregnant or breastfeeding.
  • Cannot have taken other experimental treatments recently.

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