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This is an open label single arm, multicenter, phase II study designet To assess the progression free survival (PFS) of cabozantinib in patients pretreated with one immunocheckpoint inhibitor (CPI) in monotherapy or in combination
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Inclusion criteria
Signed written informed consent
One previous anticancer treatment with a PD1/PDL1 inhibitor, as monotherapy or in combination with an angiogenesis inhibitor or anti CTLA 4, in both setting first line or adjuvant ( in this case patient having recurrence during the adjuvant treatment or within 6 months after therapy with PD1-PD-L1 therapy)
Age ≥18 years
Patients with histological diagnosis of predominant clear cells renal cell carcinoma
Measurable disease (as per RECIST 1.1 criteria) with documented radiological progression
Fertile women (<2 years after last menstruation) and men of childbearing potential must use effective methods of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilisation) during the study and for 4 months after the last dose of study treatment
All sites of disease including brain metastases (non symptomatic)
Karnofsky performance status ≥ 70%
Life expectancy greater than 3 months
The required values at baseline are as follows:
Exclusion criteria
Primary purpose
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49 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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