計劃書編號D4191C00137
NCT Number(ClinicalTrials.gov Identfier)NCT05303532
試驗執行中
2023-03-01 - 2025-09-30
Phase III
召募中5
ICD-10C00.0
上唇外側惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9140.0
上唇紅緣惡性腫瘤
ROSY-D：一項針對曾經完成 Durvalumab腫瘤試驗並經由試驗主持人判定病患臨床獲益於該治療之延伸試驗
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
非小細胞肺癌、小細胞肺癌、膽道癌、頭頸癌
試驗目的
為於安全性與耐受性監測期間，經判定在臨床試驗結束時持續獲得效益的病患，持續提供試驗治療。
藥品名稱
N/A
主成份
Durvalumab (MEDI4736)
劑型
Solution for infusion
劑量
50mg/mL
評估指標
通報嚴重不良事件直到接受最後一劑試驗治療後90天為止。
主要納入條件
核心計畫書納入條件為：
1. 提供已簽名並註明日期的書面受試者同意書 (ICF)。
2. 根據試驗主持人的判斷，病患目前正在阿斯特捷利康 (AstraZeneca)母試驗使用阿斯特捷利康 (AstraZeneca)化合物持續治療中獲得臨床效益，該試驗已達成其試驗指標，或已停止，或病患已達到母試驗計畫書中所允許的最長治療時間。
3. 納入試驗時病患能以1500 mg的固定劑量接受Q4W的durvalumab。
ROSY-D子試驗沒有其他納入條件。
1. 提供已簽名並註明日期的書面受試者同意書 (ICF)。
2. 根據試驗主持人的判斷，病患目前正在阿斯特捷利康 (AstraZeneca)母試驗使用阿斯特捷利康 (AstraZeneca)化合物持續治療中獲得臨床效益，該試驗已達成其試驗指標，或已停止，或病患已達到母試驗計畫書中所允許的最長治療時間。
3. 納入試驗時病患能以1500 mg的固定劑量接受Q4W的durvalumab。
ROSY-D子試驗沒有其他納入條件。
主要排除條件
Exclusion Criteria:
The Core Protocol exclusion criteria are.
Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
Currently receiving treatment with any prohibited medication(s).
Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical progression).
Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
The additional exclusion criteria for the ROSY-D sub-study are:
Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
The Core Protocol exclusion criteria are.
Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
Currently receiving treatment with any prohibited medication(s).
Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical progression).
Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
The additional exclusion criteria for the ROSY-D sub-study are:
Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
試驗計畫預計收納受試者人數
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台灣人數
7 人
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全球人數
147 人
