New combo aims to fight merkel cell cancer when immunotherapy fails
NCT ID NCT07472322
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 6 times
Summary
This study tests whether combining two drugs—ASTX727 (a pill) and retifanlimab (given through a vein)—can shrink tumors and control advanced Merkel cell cancer in people whose disease has worsened after standard immunotherapy. About 31 adults with stage III or IV Merkel cell cancer that cannot be removed by surgery will take the drugs for up to two years. The main goals are to check safety and see if the combination helps stop the cancer from growing or spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASTX727 (decitabine/cedazuridine) and retifanlimab
- What this could lead to
- If it works, this combination could offer a new treatment option for people with advanced Merkel cell cancer whose disease has stopped responding to standard immunotherapy.
- What could go wrong
- This is an early-phase trial with only 31 participants, so results may not apply to everyone. The combination may cause significant side effects, and it is not yet known if it will be more effective than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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