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

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

• 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 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.

Criteri di esclusione: 

• 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 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.

Schema di trattamento: 

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).

Trattamento sperimentale: 

Tivozanib in Combination with Nivolumab vs. Tivozanib Monotherapy

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-000050-26 / NCT04987203

Data di inserimento: 20.05.2022

Promotore

AVEO Pharmaceuticals, Inc.

Principal Investigator ITALIA

Istituto Nazionale Tumori IRCCS Fondazione 'G. Pascale'

Riferimento: Dr.ssa Marilena Di Napoli

Telefono: 08117770471

Email: m.dinapoli@istitutotumori.na.it

Localita: Napoli