Trial intelligence / Profile preview

SNAPI: Sitravatinib Plus Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma

NCT04904302Phase 2

Key facts

Status: Terminated
Start: May 2022
Primary completion: Mar 2026
Countries: 1
Sponsor: University of Texas MD Anderson Cancer Center
Modality: Small Molecules

Drugs: sitravatinib
Conditions: clear cell renal cell carcinoma (ccRCC)

Overview

Phase 2, open-label, single-arm trial of sitravatinib in clear cell renal cell carcinoma (ccRCC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Objective Response Rate at 24 weeks and Disease Control Rate at 24 weeks. Started May 2022; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment (sitravatinib, nivolumab)
Patients receive sitravatinib PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks.

Who it enrols

Adult patients with metastatic clear cell RCC who have progressed on 1 or 2 prior lines of therapy including a PD-1/PD-L1 inhibitor, cabozantinib, or lenvatinib, with adequate organ function and Karnofsky performance status >= 70.

Endpoints

Primary

Objective Response Rate24 weeks
Disease Control Rate24 weeks

Secondary

Overall Survival1 year
Progression-Free Survival1 year
Duration of Response1 year
Incidence of Adverse EventsUp to 6 years
Health-Related Quality of LifeUp to 24 weeks

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