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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the safety of DEC-C in combination with Nivolumab unresectable, locally advanced, or metastatic mucosal melanoma patients.
Secondary outcome measures
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 outcome measures
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral Decitabine/Cedazuridine (DEC-C) and Nivolumab in Mucosal MelanomaExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,496 Total Patients Enrolled
10 Trials studying Melanoma
316 Patients Enrolled for Melanoma
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,605 Total Patients Enrolled
6 Trials studying Melanoma
94 Patients Enrolled for Melanoma
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,554 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05089370 — Phase 1 & 2
Melanoma Research Study Groups: Oral Decitabine/Cedazuridine (DEC-C) and Nivolumab in Mucosal Melanoma
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05089370 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05089370 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation recruiting geriatric participants?

"This trial is seeking participants who are above the age of consent and not yet a centenarian."

Answered by AI

Is the enrolment process for this research still open?

"Affirmative. As evidenced by the information on clinicaltrials.gov, this research endeavour is presently recruiting participants. It was initially posted on May 25th 2022 and requires 30 patients to be recruited from a single site."

Answered by AI

Am I eligible to join this medical research project?

"This clinical trial is targeting 30 individuals, aged 18 to 100 years old, who have been diagnosed with malignant melanoma. Furthermore, potential participants must meet certain criteria such as having radiographically detectable disease according to immune-RECIST (iRECIST), satisfactory hepatic and bone marrow function, ECOG performance status of 0 or 1; in addition they need to sign a consent form and be available for the duration of the study. Prior treatment including anti-PD1/CTLA4 immunotherapy must also not exceed one month before initiating this new therapy."

Answered by AI

Has the combined application of Oral Decitabine/Cedazuridine (DEC-C) and Nivolumab been tested in prior clinical trials?

"Presently, 97 live studies have reached phase 3 of clinical trials for Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab. Of those 818 overall investigations into this treatment, the majority are situated in Reggio Emilia and Foggia; however there are 41256 locations worldwide running similar research."

Answered by AI

What is the current capacity for participation in this clinical experiment?

"Affirmative, the clinical trial page hosted on clinicaltrials.gov declares that this medical experiment is currently enrolling participants. This study was posted on May 25th 2022 and revised around the same time; they are seeking 30 volunteers at one site."

Answered by AI

In which treatments has Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab demonstrated efficacy?

"Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab has been clinically proven to effectively treat malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma
2022. "Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05089370.
~4 spots leftby Jul 2024
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