Klinische Studie
A Phase II, multicenter, open-label study of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic renal cell carcinoma with a clear-cell component who progressed after 1st line treatment with checkpoint inhibitors.(CABOPOINT)STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien(1) Subjects must provide a signed informed consent prior to any study-related procedures;
(2) Male or female subjects must be aged ≥18 years on the day the informed consent is signed;
(3) Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component;
(4) Subjects must have radiographic disease progression, according to Investigator’s judgement, following 1st line treatment with CPI (ipilimumab plus nivolumab) (Cohort A) or CPI in combination with VEGF-targeted therapy (Cohort B);
(5) Subjects present ≥1 target lesion according to RECIST 1.1 per Investigator;
Wesentliche Ausschlusskriterien(1) Has a diagnosis of predominant non clear-cell RCC;
(2) Inability to swallow tablets;
(3) Was treated with any other investigational medicinal product (IMP) within the last 30 days before study entry;
(4) Was previously treated with cabozantinib;
(5) Presents untreated brain or leptomeningeal metastases, or current clinical or radiological progression of known brain metastase
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de