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Набор скоро начнётся NCT07472322

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

Фаза I / Фаза II С лечением Merkel Cell Carcinoma Merkel Cell Carcinoma, Stage III Merkel Cell Carcinoma, Stage IV

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ASTX727 + retifanlimab.
Кому может быть актуально
Состояния в реестре: Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III, Merkel Cell Carcinoma, Stage IV. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Препарат ASTX727 + retifanlimab
    Participants take oral ASTX727 and receive retifanlimab through a vein

Первичные конечные точки

  • Percentage of subjects with treatment-emergent adverse events [Срок оценки: Up to 27 months (2 years plus 90 days)]
Вторичные конечные точки (6)
  • Overall Response Rate (ORR) [Срок оценки: Up to 4 years]
  • Disease Control Rate (DCR) [Срок оценки: Up to 4 years]
  • Progression-free Survival (PFS) [Срок оценки: Up to 4 years]
  • Overall Survival (OS) [Срок оценки: Up to 4 years]
  • Duration of Response (DoR) [Срок оценки: Up to 4 years]
  • Percentage of participants with tumor reduction [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Wisconsin-Carbone Cancer Center — Madison

Идентификаторы

NCT: NCT07472322 · 2026-0149 · UWMSN | SMPH | DOM Hematology · Protocol Version 3/2/26 · UW26001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗