Trial Search Results
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).
Stanford is currently accepting patients for this trial.
AVEO Pharmaceuticals, Inc.
- Drug: Tivozanib
- Drug: Nivolumab
- Radiographic disease progression during or following at least 6 weeks of treatment
with ICI for locally advanced or metastatic RCC with a clear cell component either in
first- or second-line treatment.
- Subjects must have recovered from the adverse events of prior therapy or returned to
- Histologically or cytologically confirmed RCC with a clear cell component.
- Measurable disease per RECIST criteria Version 1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- All participants must follow protocol defined contraceptive measures.
- More than 2 prior lines of therapy in the advanced or metastatic setting.
- History of life-threatening toxicity related to prior immune therapy.
- Active, known, or suspected autoimmune disease as well as those that required
discontinuation of prior immuno-oncological (IO) therapy due to immune mediated AEs.
- Uncontrolled hypertension.
- More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic
- Subjects on immune suppressive therapy for organ transplant or subjects with a history
of genetic or acquired immune suppression disease such as human immunodeficiency virus
(HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history
of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and
are on established antiretroviral therapy which does not include a cytochrome P450
(CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400
copies/mL, are eligible].
- History of clinically significant interstitial lung disease or current non-infectious
Ages Eligible for Study
18 Years - 130 Years
Genders Eligible for Study