NL-OMON55079招募中2 期
Cemiplimab treatment in patients with locally advanced and metastatic secondary angiosarcomas - Cemiplimab for secondary angiosarcomas
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult patient aged >= 18 years.
- •2. Signed written informed consent.
- •3. Histologically confirmed diagnosis of progressive unresectable locally
- •advanced or metastatic secondary angiosarcoma.
- •4. Patients in the first line of systemic treatment unfit for chemotherapy and
- •patients in advanced lines of systemic treatment
- •5. Measurable disease per RECIST 1.1 or per physical examination / daylight
- •photography (WHO Offset Publication No. 48) as determined by the investigator.
- •6. Tumour tissue material available (archival or recent tumour biopsy).
- •7. WHO ECOG 0-2.
- •8. Hepatic function:
- •a. Total bilirubin <= 1.5 x ULN (if liver metastases: <= 3 x ULN).
- •b. Transaminases <= 3 x ULN (if liver metastases: <= 5 x ULN).
- •c. Patients with Gilbert*s Disease and total bilirubin up to 3x ULN may be
- •eligible after communication with and approval from the medical monitor
- •d. Alkaline phosphatase <= 2.5 x ULN (if liver OR bone metastases <=5 x ULN).
- •9. Renal function: serum creatinine <= 2 x ULN or estimated CrCl > 30 mL/min.
- •10. Creatine phosphokinase (CPK) (also known as CK [creatine kinase]) elevation
- •<= grade 2
- •11. Bone marrow function:
- •a. Hemoglobulin >= 9.0 g/dL.
- •b. ANC >= 1.5 x 109/L.
- •c. Platelet count >= 75 x 109/L.
- •12. Expected life expectancy of at least 3 months as judged by the
- •investigator.
排除标准
- •1. Ongoing or recent (within 5 years) evidence of significant autoimmune
- •disease that required treatment with systemic immunosuppressive treatments,
- •which may suggest risk for irAEs. The following are not exclusionary: vitiligo,
- •childhood asthma that has resolved, type 1 Diabetes mellitus, residual
- •hypothyroidism that required only hormone therapy, or psoriasis that does not
- •require systematic treatment.
- •2. Prior treatment with immune checkpoint inhibitors.
- •3. Continuous immunosuppressive corticosteroid treatment (doses > 10 mg
- •prednisone daily or equivalent) within 4 weeks prior to the first dose of
- •cemiplimab. Note: patients who require a brief course of steroids (e.g. as
- •prophylaxis for imaging studies) are not excluded.
- •4. Active uncontrolled infection requiring therapy, including infection with
- •HIV, active infection with HBV or HCV.
- •5. History of pneumonitis within the last 5 years.
- •6. Untreated brain metastasis(es) that may be considered active.
- •a. Note in clarification: Patients with previously treated brain metastases may
- •participate provided that the lesion(s) is (are) stable (without evidence of
- •progression for at least 6 weeks on imaging obtained in the screening period),
- •and there is no evidence of new or enlarging brain metastases, and the patients
- •do not require any immunosuppressive doses of systemic corticosteroids for
- •management of brain metastasis(es) within 28 days of the first dose of
- •cemiplimab.
- •7. Patients with allergy or hypersensitivity to cemiplimab or to any of the
- •excipients must be excluded. Specifically, because of the presence of trace
- •components in cemiplimab, patients with allergy or hypersensitivity to
- •doxycycline or tetracycline are excluded.
- •8. History of documented allergic reactions or acute hypersensitivity reaction
- •attributed to antibody treatments
- •9. Patients with a history of solid organ transplant (patients with prior
- •corneal transplants may be allowed to enroll after discussion with and approval
- •from the medical monitor).
- •10. Any anticancer treatment other than radiation therapy (chemotherapy,
- •targeted systemic therapy, imiquimod, photodynamic therapy), investigational or
- •standard of care, within 30 days of the initial administration of cemiplimab or
- •planned to occur during the study period
- •11. Receipt of live vaccines (including attenuated) within 30 days of first
- •study treatment
- •12. Prior use of PI3K-D inhibitors
- •13. Women of childbearing potential (WOCBP)*, or sexually active men, who are
- •unwilling to practice highly effective contraception prior to the initial
- •dose/start of the first treatment prior to the start of the first treatment,
- •during the study, and for at least 6 months after the last dose.
- •14. Breastfeeding
- •15. Positive serum pregnancy test (a false positive pregnancy test, if
- •demonstrated by serial measurements and negative ultrasound, will not be
- •exclusionary, upon communication with and approval from the medical monitor)
- •16. Any other condition that might interfere with experimental treatment and
- •the study procedures as judged by the investigator.
研究者
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