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Checkpoint Inhibitor

DEC-C + Nivolumab for Melanoma

Phase 1 & 2

Recruiting

Led By Martin McCarter

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have adequate renal function

Patients must have adequate bone marrow function

Must not have

Patients with leptomeningeal disease

Patients must not have known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a combination of drugs that target epigenetic immune repression and RIG-I activity can improve the effectiveness of Nivolumab treatment for patients with mucosal melanoma.

Who is the study for?

This trial is for adults aged 18-100 with advanced mucosal melanoma, who may have had prior immune therapy. They must be able to undergo biopsies, have good organ function, and not be pregnant or breastfeeding. Participants need a negative pregnancy test and agree to use contraception if applicable. HIV-positive individuals can join if they meet certain conditions.

What is being tested?

The study tests Oral Decitabine/Cedazuridine (DEC-C) combined with Nivolumab in patients with mucosal melanoma. It aims to see if DEC-C can boost the body's immune response against cancer by activating specific pathways and increasing tumor-fighting cells while on Nivolumab treatment.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, fatigue, possible infusion-related reactions from Nivolumab, and issues affecting blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal.

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My bone marrow is functioning well.

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My liver is working well.

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My melanoma is advanced, cannot be surgically removed, and is located in specific areas.

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I am fully active or have some restrictions but can still take care of myself.

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My cancer can be measured by scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to the lining of my brain and spinal cord.

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I do not have an active Hepatitis B or C infection.

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I have never needed steroids for non-infectious lung inflammation.

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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I am not on high-dose steroids or other immunosuppressants.

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I am not taking any medications broken down by the enzyme CDA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the safety of DEC-C in combination with Nivolumab unresectable, locally advanced, or metastatic mucosal melanoma patients.

Secondary study objectives

Determine if the addition of DEC-C to Nivolumab increases progression free survival (PFS) and overall survival (OS) in unresectable, locally advanced, or metastatic mucosal melanoma patients.

Determine the response rate to DEC-C in combination with Nivolumab in unresectable, locally advanced, or metastatic mucosal melanoma patients

Other study objectives

Determine the effect of DEC-C in combination with Nivolumab on circulating and tumor innate immune sensing cytokines and proteins.

Determine the effect of DEC-C in combination with Nivolumab on global hypomethylation and RIG-I pathway gene expression in circulating cells and tumor cells.

Evaluate the effect of DEC-C in combination with Nivolumab on circulating and tumor immune cell profiles.