Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Mela… (NCT05089370) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma
United States8 participantsStarted 2022-06-20
Plain-language summary
Activation of the RIG-I innate immune pathway and increased expression of tumor antigens and pro-immune genes by DEC-C during Nivolumab treatment may enhance the frequency and activity of anti-tumor immune cells (CD4+ and CD8+ T-cells, NK cells) and reduce the frequency and activity of immunosuppressive cells. This may increase the overall effectiveness and success of Nivolumab treatment. This pilot clinical trial will demonstrate whether combinatorial immunotherapeutic approaches that target epigenetic immune repression and RIG-I activity can favorably alter the tumor immune cell microenvironment and benefit patients with mucosal melanoma.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provision to sign and date the consent form.
✓. Stated willingness to comply with all study procedures and be available for the duration of the study.
✓. Be a male or female aged 18-100.
✓. Histologically confirmed diagnosis of advanced mucosal melanoma (unresectable Stage III or Stage IV Melanoma). Anatomical locations for primary site of mucosal melanoma include oral cavity (excluding lip), nasopharynx, vagina/vulva, and rectum.
✓. Prior immune checkpoint blockade therapy, including anti-PD1 and anti-CTLA4 for unresectable locally advanced or metastatic disease, is allowed. The combination of anti-PD1 and anti-CTLA4 is also allowed as a prior line of therapy. Study therapy must be initiated within 30 days of previous immune checkpoint blockade therapy (excluding adjuvant anti-PD1 and anti-CTLA4).
✓. Patients must have systemic cross-sectional imaging (PET/CT or CT of chest, abdomen, and pelvis) with radiographically measurable, by immune-RECIST (RECIST) criteria, or clinically measurable disease.
✓. Previously treated brain metastatic disease is allowed. Stability of brain metastases must be confirmed by MRI \> 4 weeks from most recent treatment and within 4 weeks of initiating study therapy.
✓
What they're measuring
1
Determine the safety of DEC-C in combination with Nivolumab unresectable, locally advanced, or metastatic mucosal melanoma patients.
. Patients must have an ECOG performance status of 0 or 1 (Table 5).
Exclusion criteria
✕. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, treated and stable thyroid cancer, adequately treated Stage I cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
✕. Patients must not currently be on other drugs metabolized by CDA.
✕. Prior cytotoxic chemotherapy treatment received within 30 days of study enrollment.
✕. Patients with leptomeningeal disease.
✕. Current immunosuppressive therapy including \>10mg/day of prednisone within 14 days of enrollment is not permitted. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
✕. Patients must not have known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection prior to registration.
✕. Patients must not have active autoimmune disease that has required systemic treatment in past 2 years from date of enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
✕. Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.