Back to search results

ASTX727 & Retifanlimab for Advanced Merkel Cell Carcinoma

This study is for people with advanced Merkel cell carcinoma (a type of skin cancer) that has worsened after previous treatment with anti-PD-(L)1 drugs. Researchers want to see if combining two drugs, ASTX727 (taken by mouth) and retifanlimab (given through a vein), is safe and can help shrink the cancer or stop it from growing or spreading. They will also compare this combination to standard treatments. You might be able to join if you are at least 18 years old and have unresectable (cannot be removed by surgery) stage III or IV Merkel cell carcinoma. The main goal is to track any side effects over about 27 months.

Study design
This is an interventional study with a planned enrollment of 31 participants. It is designed to evaluate the safety and effectiveness of combining two specific drugs.
What's involved
You would take oral ASTX727 and receive retifanlimab through a vein for about 2 years. You would visit the clinic every two weeks for checkups and tests.
Compensation
Not stated in the trial record.
Follow-up
Your health and any side effects will be monitored for up to 27 months (2 years plus 90 days) after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07472322

ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~31 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:ASTX727 + retifanlimab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of subjects with treatment-emergent adverse events
Measured over Up to 27 months (2 years plus 90 days)

Conditions

Merkel Cell Carcinoma
Merkel Cell Carcinoma, Stage III
Merkel Cell Carcinoma, Stage IV

Explore related trials

Merkel Cell Carcinoma

NCT07472322

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Wisconsin-Carbone Cancer Center

    Madison, Wisconsinstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vincent Ma, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of subjects with treatment-emergent adverse eventsUp to 27 months (2 years plus 90 days)

    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.