IO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor - LIO-1

Clovis Oncology, Inc.0 个研究点目标入组 161 人开始时间: 2020年9月21日最近更新: 2022年8月8日

试验速览

暂无简介。

•= 18 years of age
•Adequate organ function
•Life expectancy = 3 months
•Women of childbearing potential must have a negative plasma or serum pregnancy test
•Advanced/metastatic solid tumor
•Availability of tumor tissue at screening
•ECOG performance status of 0 to 1
•Measurable disease (RECIST v1.1)
•Advanced, recurrent, or metastatic gynecological solid tumor
•Willing and able to provide an additional biopsy after 4 weeks of
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 97
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

•Prior treatment with lucitanib
•Active second malignancy
•Active central nervous system brain metastases
•Pre-existing duodenal stent or any gastrointestinal disorder
•Known history of HIV or AIDS; positive result of hepatitis B or C
•Evidence of interstitial lung disease, active pneumonitis,
•myocarditis, or history of myocarditis
•Active, known, or suspected autoimmune disease (e.g.,
•autoimmune hepatitis)
•Condition requiring systemic treatment with corticosteroids or
•other immune suppressive medications
•Unstable or uncontrolled hypertension
•(greater than 140/90 mmHg)
•Prior treatment with a VEGFR-tyrosine kinase inhibitor
•NOTE: Bevacizumab is permitted in the first line and second line treatment (including maintenance) of advanced ovarian cancer as first line treatment of metastatic or recurrent cervical cancer in combination with chemotherapy (including maintenance), or as first-line and secondline treatment in combination with chemotherapy (including maintenance) or as single-agent for recurrent or metastatic endometrial cancer. An EMA- or FDA-approved biosimilar is an acceptable substitutefor bevacizumab.
•History of life-threatening toxicity related to prior immune therapy (eg, anti CTLA 4 or anti PD 1/PD L1 treatment or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hypothyroidism).

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