A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma

Takara Bio Inc.0 个研究点目标入组 25 人开始时间: 2017年5月23日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with histologically confirmed Stage IIIB, IIIC or IV unresectable or metastatic melanoma except uveal melanoma, who must have a history of treatment (chemotherapy, molecular targeted therapy, or anti PD-1 antibody therapy).
•2) Patients must have measurable non-visceral lesion(s) that are evaluable by the modified World Health Organization (mWHO) criteria and immune-related response criteria (irRC).
•3) Patients must be more than 20 years of age.
•4) Patients must have a life expectancy more than 24 weeks.
•5) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

•1) Patients who were previously treated with ipilimumab by intravenous infusion.
•2) Patients receiving chemotherapy or molecularly targeted drug or anti-PD-1 antibody treatment or radiotherapy or immunotherapy within 4 weeks prior to initiating study treatment.
•3) Patients with a history of Grade 4 adverse events caused by chemotherapy, molecularly targeted drug, anti-PD-1 antibody treatment, radiotherapy or immunotherapy conducted more than 4 weeks prior to TBI-1401(HF10) treatment, or presence of such adverse events of Grade 2 or greater, except alopecia and adverse events controlled by a treatment.
•4) Patients receiving anti-herpes medication within 1 week prior to initiating TBI-1401(HF10) administration, except local treatment such as ointment.
•5) Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.

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