ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ASTX727 + retifanlimab.
- Who it may be relevant to
- Registry conditions: Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage IV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed 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.
Interventions
- Drug ASTX727 + retifanlimab
Participants take oral ASTX727 and receive retifanlimab through a vein
Primary outcome measures
- Percentage of subjects with treatment-emergent adverse events [Time frame: Up to 27 months (2 years plus 90 days)]
Secondary outcome measures (6)
- Overall Response Rate (ORR) [Time frame: Up to 4 years]
- Disease Control Rate (DCR) [Time frame: Up to 4 years]
- Progression-free Survival (PFS) [Time frame: Up to 4 years]
- Overall Survival (OS) [Time frame: Up to 4 years]
- Duration of Response (DoR) [Time frame: Up to 4 years]
- Percentage of participants with tumor reduction [Time frame: Up to 4 years]
Eligibility criteria
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-L1 inhibitor. Relapsed/refractory disease from prior adjuvant PD-1 or PD-L1 inhibitor is permitted. Prior treatment with retifanlimab is permitted.
- Demonstrate adequate organ and marrow function; all screening labs to be obtained within 28 days prior to registration
Exclusion criteria
- Prior treatment with a hypomethylating agent (HMA) (e.g., azacitidine, decitabine, guadecitabine)
- History of clinically significant intolerance, hypersensitivity, or treatment discontinuation of an anti-PD-1 or anti-PD-L1 inhibitor due to grade 3 or greater immune-related adverse events (irAEs). Participants who are able to be successfully rechallenged with anti-PD-(L)1 inhibitor without recurrence of grade 3 or greater irAEs are permitted on study. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study drug(s) may be included (e.g. hearing loss, hypothyroidism, adrenal insufficiency, type 1 diabetes, or other endocrinopathies) after consultation with the sponsor investigator
- Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months before the first dose of study treatment
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration
- Active infection requiring systemic therapy within 7 days prior to registration
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin-Carbone Cancer Center — Madison
Identifiers
NCT: NCT07472322 · 2026-0149 · UWMSN | SMPH | DOM Hematology · Protocol Version 3/2/26 · UW26001