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NCT05089370 · ClinicalTrials.gov registry record · Phase 1
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma
A Phase 1 study of Malignant Melanoma, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05089370: Active Phase 1 study of Malignant Melanoma, sponsored by University of Colorado, Denver.
NCT05089370 is a Phase 1 study of Malignant Melanoma that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 8 participants, below the 183-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05089370, a Phase 1 study of Malignant Melanoma, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Determine the safety and tolerability of DEC-C in combination with Nivolumab by evaluating adverse events (AEs) using CTCAEv5.0 criteria and establishing the recommended phase 2 dose (RP2D) of DEC-C.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What the registry record for NCT05089370 still lists
NCT05089370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 183-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab is the first listed.
NCT05089370 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05089370 about?
NCT05089370 is a clinical study titled "Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma". 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 immunosuppres...
What is the current status of trial NCT05089370?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-06-20. Estimated completion is 2026-10.
What conditions does trial NCT05089370 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT05089370?
The interventions under investigation include: Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05089370?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05089370 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05089370's enrollment target sits among peer trials
8 27th of 28 higher than 2 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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