ivolumab monotherapy in Rare tumor patients with mismatch repair deficiency biomarker: A phase II trial - ROCK trial

Kan Yonemori, National Cancer Center Hospital0 个研究点目标入组 15 人开始时间: 2018年4月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Patients diagnosed with rare cancers or rare histological subtype of a common cancer
•2)Patients who have a cancer type that nivolumab is not approved for.
•3)Diagnosed as dMMR or MSI-high
•4)Patient has a metastatic, non-resectable, or reccurent lesion
•5)Patients have no further standard treatment.
•6)No symptomatic brain metastasis, carcinomatous meningitis, vertebral metastasis requiring radiotherapy or surgery
•7)No cardiac effusion, pleural effusion and ascites requiring any treatment
•8)Aged 16 or above at the time of registration
•9)Performance Status 0 or 1
•10)One or more measurable lesions confirmed by contrast enhanced CT
•11)No prior treatment of immune checkpoint inhibitors
•12)Not receiving prednisolone or any immunosuppressive agents within 14 days before registration
•13)Not received anti-cancer therapy within 28 days before registration
•14)Not undergone surgery under general anesthesia within 28 days before registration
•15)Not received radiotherapy within 28 days before registration
•16)Not received radioactive pharmaceuticals within 56 days before registration
•17)Patients received laboratory tests within 14 days before registration and have adequate organ function
•18)Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration
•19)Given consent to contraception
•20)Written informed consent

•1) Active double cancer
•2) Infections requiring systemic therapy
•3) Active gastrointestinal ulcer
•4) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
•5) History of hypersensitivity reaction to antibody agents
•6) Active autoimmune disease
•7) HIV antibody positive, HBV-DNA positive, etc.
•8) Pregnant or breast-feeding women, or women suspected of being pregnant
•9) Mental disease interfering taking part in the trial

发起方

Kan Yonemori, National Cancer Center Hospital