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

Trial ID or NCT#

NCT04987203

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 130 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 baseline. - 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:
  1. - 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 setting. - 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 pneumonitis.
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Aidan Keil O'Brien
650-723-3046

View on ClinicalTrials.gov