NCT07472322尚未招募1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percentage of subjects with treatment-emergent adverse events
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Merkel cell carcinoma
Experimental
Participants with unresectable Merkel cell carcinoma who progressed on prior PD-1 or PD-L1 inhibitor
干预措施: ASTX727 + retifanlimab (Drug)
结局指标
主要结局
Percentage of subjects with treatment-emergent adverse events
时间窗: Up 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.
次要结局
- 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)
- Percentage of participants with tumor reduction(Up to 4 years)
研究者
研究点 (1)
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