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A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor
The primary objective of this study is to compare the progression-free survival (PFS) of tivozanib in combination with nivolumab to tivozanib in subjects with renal cell carcinoma (RCC) who have progressed following 1 or 2 lines of therapy which included an immune checkpoint inhibitory (ICI).
• If you take part in this study, you should follow the study procedures and go to all of the study visits. • Please inform the study doctor if you will not be able to go to a visit. • You must store tivozanib per the instructions on the label, and in a secure location. In your study drug diary, you must record the dates you take each tivozanib dose. You must bring the diary, the bottle of tivozanib (even if it is empty), and unused capsules (if applicable) to each of your visits to the study center. • You should report any changes to your well-being, including any side effects, to the study doctor. • It is also important that you tell the study staff about any other medication you are taking before and during the study. Tell the study doctor before you start a new medication. • You should not be taking certain medications while you are in this study. The study doctor will discuss these with you. • You should not consume grapefruit juice during the study. • Women who can get pregnant and men along with their partner(s) who can get pregnant, will need to use birth control while in this study. Check with the study doctor about what kind of birth control methods to use and how long to use them for.
Subjects must have recovered from the AEs of prior therapy or returned to baseline
Patient must have histologically or cytologically confirmed renal cell carcinoma (RCC) with a clear cell component
Patient must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient has a history of allergy or hypersensitivity to study drug or components
Patient has a history of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures
Patient has an active, known, or suspected autoimmune disease
Patient has uncontrolled hypertension, SBP > 150 mmHg or DBP > 100 mmHg on 2 or more antihypertensive medications