
==== Front
Neurooncol Adv
Neurooncol Adv
noa
Neuro-Oncology Advances
2632-2498
Oxford University Press US

10.1093/noajnl/vdae090.091
vdae090.091
Final Category: Ongoing Clinical Trials
AcademicSubjects/MED00300
AcademicSubjects/MED00310
OCTS-06 A PHASE II STUDY OF NIVOLUMAB WITH IPILIMUMAB AND CABOZANTINIB IN PATIENTS WITH UNTREATED RENAL CELL CARCINOMA BRAIN METASTASES
Wang Jianbo MD Anderson Cancer Center, Houston, USA

Campbell Matthew md Anderson Cancer Center, Houston, USA

Shah Amishi Y md Anderson Cancer Center, Houston, USA

Goswami Sangeeta MD Anderson Cancer Center, Houston, USA

Msaouel Pavlos MD Anderson Cancer Center, Houston, USA

Alhalabi Omar MD Anderson Cancer Center, Houston, USA

Hahn Andrew MD Anderson Cancer Center, Houston, USA

Kovitz Craig md Anderson Cancer Center, Houston, USA

Bagi Jana MD Anderson Cancer Center, Houston, USA

Araujo John md Anderson Cancer Center, Houston, USA

Gao Jianjun md Anderson Cancer Center, Houston, USA

Lin John md Anderson Cancer Center, Houston, USA

Zurita Amado MD Anderson Cancer Center, Houston, USA

Jonasch Eric MD Anderson Cancer Center, Houston, USA

Corn Paul md Anderson Cancer Center, Houston, USA

Tannir Nizar MD Anderson Cancer Center, Houston, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i27i28
© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

BACKGROUND

The incidence of brain metastases(mets) at the diagnosis of renal cell carcinoma (RCC) is 1.51%, and around 12% of patients(pts) with advanced RCC (aRCC) had brain mets. Brain mets confer a poor prognosis. Although systemic therapies including tyrosine kinase inhibitors and immune checkpoint inhibitors have been explored in aRCC pts with brain mets, prospective data are lacking. Cabozantinib was FDA approved for pts with aRCC and retrospective studies have suggested activity in patients with intracranial tumors. The phase III COSMIC-313 trial recently evaluated cabozantinib in combination with nivolumab and ipilimumab and demonstrated significantly improved progression-free survival (PFS) in previously untreated pts with aRCC. However, the role of this combination in aRCC pts with brain mets remains undefined. We propose a study to assess the safety and efficacy of cabozantinib in combination with nivolumab/ipilimumab in RCC pts with untreated brain mets.

METHODS

This is a phase II study to assess the safety and efficacy of the combination of nivolumab with ipilimumab and cabozantinib in pts with untreated brain mets from RCC. Planned accrual is 40 pts. Pts will receive nivolumab (3mg/kg) and ipilimumab (1mg/kg) IV every 3 weeks for 4 doses and cabozantinib 40mg daily. Then pts will be treated with nivolumab 480mg IV Q 4 weeks and cabozantinib 40mg daily. A lead-in group of 6 pts will be closely monitored for dose limiting toxicities (DLT). If stopping criteria (>3 patients develop DLTs) is met, then treatment will be switched to nivolumab plus cabozantinib omitting ipilimumab. The primary objective is intracranial progression free survival (PFS). Secondary objectives include intracranial safety, objective response rate (intracranial + extracranial) by modified RECIST v1.1 and RECIST v1.1, extracranial PFS, overall survival and correlative studies. As of 4/2024, Lead-in group has been completed with acceptable rate of DLT. Clinical trial information: NCT05048212.
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