UW26001 Phase I/II Study on the Safety, Tolerability, and Preliminary Efficacy of ASTX727 (Decitabine/Cedazuridine) and Retifanlimab-dlwr in Patients With Advanced Merkel Cell Carcinoma Who Have Progressed on Anti-PD-(L)1 Inhibitor
University of Wisconsin, Madison
Summary
The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are: * Can the combination shrink cancer and lower the chance of the cancer growing or spreading? * Is the combination better than standard of care for Merkel cell cancer? Participants will: * Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years. * Visit the clinic once every 2 weeks for checkups and tests
Description
This study is being done to see if combining ASTX727 (decitabine/cedazuridine) with retifanlimab-dlwr is safe and confers clinical benefit in patients with advanced Merkel cell carcinoma who have progressed on anti-PD-(L)1 inhibitor therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals age ≥ 18 years at the time of consent * ECOG Performance Status of 0-2 * Histological or cytological evidence/confirmation of Merkel cell carcinoma (MCC) * Must have unresectable stage III/IV MCC per American Joint Committee on Cancer (AJCC) 8th edition. Participants must be considered unresectable based on the judgment of the treating physician * Participants must have progressed on prior programmed cell death protein-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor-based therapy. Participants must have received at least 2 doses of anti-PD-1 or anti-PD…
Interventions
- DrugASTX727 + retifanlimab
Participants take oral ASTX727 and receive retifanlimab through a vein
Location
- University of Wisconsin-Carbone Cancer CenterMadison, Wisconsin