Trial intelligence / Profile preview

Cabozantinib and Nivolumab in Older Patients with Renal Cell Carcinoma

NCT06934057Phase 4

Key facts

Status
Recruiting
Start
May 2025
Primary completion
Apr 2028
Countries
1
Sponsor
Gustave Roussy
Modality
Small Molecules
Conditions
renal cell carcinoma (RCC)
01

Overview

Phase 4, open-label, single-arm trial of cabozantinib in renal cell carcinoma (RCC), sponsored by Gustave Roussy. Primary endpoints: Starting dose of Cabozantinib at 24 weeks, Dose interruption of Cabozantinib at 24 weeks and 1 more. Started May 2025; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Cabozantinib-Nivolumab

    Standard of care Nivolumab + Cabozantinib with geriatric evaluation.

03

Who it enrols

Patients aged 70 or older with confirmed advanced or metastatic renal-cell carcinoma who have not been previously treated in the metastatic setting.

04

Endpoints

Primary

  • Starting dose of Cabozantinib

  • Dose interruption of Cabozantinib

  • Dose modifications of Cabozantinib

Secondary

  • Overall Response Rate

  • Overall Survival

  • Progression-Free Survival

  • Duration of Response

  • Frequency of adverse events according to CTCAE V5

  • Frequency of adverse events according to PRO-CTCAE

  • Quality of Life - FACT-G

  • Quality of Life - FACIT TS-G

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