Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Not Recruiting

Trial ID: NCT04987203


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).

Official Title

TiNivo-2: 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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - 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 to grade ≤ 1 or

   - 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.

Exclusion Criteria:

   - Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first
   line setting followed by a single agent immune checkpoint inhibitor (ICI) in the
   second line setting; b. More than 2 prior lines of therapy in the advanced or
   metastatic setting.

   - History of life-threatening toxicity related to prior immune therapy.

   - Active 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


drug: Tivozanib

drug: Nivolumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Aidan Keil O'Brien

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