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
Sponsor study identifier
Secondary identifiers
OTHER · UW Madison
OTHER · UW Madison
OTHER · UW Madison
interventional
31
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2026
Actual (reported)March 16, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of subjects with treatment-emergent adverse events
Adverse events will be measured using NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Grade 3 or greater non-hematological, grade 4 or greater treatment-emergent AEs, and instances where treatment has to be discontinued will be calculated for this measure.
Up to 27 months (2 years plus 90 days)
Overall Response Rate (ORR)
Up to 4 years
Disease Control Rate (DCR)
Up to 4 years
Progression-free Survival (PFS)
Up to 4 years
Overall Survival (OS)
Up to 4 years
Duration of Response (DoR)
Up to 4 years
Participants with unresectable Merkel cell carcinoma who progressed on prior PD-1 or PD-L1 inhibitor
Participants take oral ASTX727 and receive retifanlimab through a vein
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Vincent Ma, MD
University of Wisconsin, Madison
First Submitted
March 10, 2026
First Posted
March 16, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2031
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 29, 2026
Record last verified: 2026-08
Researchers must have local IRB approval for their study that is to include study of the biospecimens and accompanying data. Release of biospecimens to non-UW researchers will be performed according to all UW regulatory policies. Tissue (including blood) specimen as part of this research will be primarily stored at UW and may be sent to an outside lab/facility to achieve the objectives of the study. No study data or patient health information will be shared with a third party.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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