drugset / Trial / NCT05089370
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma
Phase 1/2
Active not recruiting
8 enrolled
University of Colorado, Denver
National Comprehensive Cancer Network · collabTaiho Oncology, Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-06-20
- Primary completion
- 2026-08-31
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cedazuridine | Small molecule | — | — |
| Subject | Decitabine | Small molecule | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |