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

10.1093/noajnl/vdae090.044
vdae090.044
Final Category: Immuno-Oncology Approaches
AcademicSubjects/MED00300
AcademicSubjects/MED00310
IMUN-05 PHASE II STUDY OF NIVOLUMAB (NIVO) IN COMBINATION WITH RELATLIMAB (RELA) IN PATIENTS WITH ACTIVE MELANOMA BRAIN METASTASES (MBM)
Phillips Suzanne The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Burton Elizabeth The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Oliva Isabella Claudia Glitza The University of Texas MD Anderson Cancer Center, Houston, TX, USA

McQuade Jennifer The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Amaria Rodabe The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Diab Adi The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Wong Michael The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Chung Caroline The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Milton Denái The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Malke Jared The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Simon Julie The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Wefel Jeffrey The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Li Jing The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Davies Michael The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Tawbi Hussein The University of Texas MD Anderson Cancer Center, Houston, TX, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i14i15
© 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

More than half of patients diagnosed with metastatic melanoma (MM) will develop brain metastases. Despite this prevalence, these patients are excluded from most clinical trials. The CheckMate 204 study combining ipilimumab (3mg/kg) plus nivo (1mg/kg) for patients with asymptomatic MBM revealed an intracranial (IC) response in 54% of patients. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 55% of patients. RELATIVITY-047, a global phase II/III randomized study, reported on the fixed-dose combination of nivo/rela (480 mg/160 mg) compared to nivo (480 mg) alone for patients with advanced unresectable and untreated melanoma. This combination demonstrated significantly improved PFS compared to anti-PD-1 monotherapy. Grade 3/4 TRAEs occurred in 21% of patients in the combination group compared to 11% in the monotherapy group with no new safety signals. The nivo/rela combination has FDA approval for the treatment of patients with MM but has not been studied in patients with MBM.

METHODS

This single arm, single center phase II trial evaluates the safety and efficacy of nivo/rela in patients with MBM. 30 MBM patients who are asymptomatic and treatment naïve to anti-PD-1 therapy will be enrolled. Patients are treated with nivo/rela (480 mg/160 mg) every 4 weeks for up to 25 cycles, disease progression, or unacceptable toxicity. The primary objective is to evaluate IC response (CR + PR) by MRI per modified RECIST 1.1 criteria. Monitoring for futility will be performed using the Bayesian Optimal Phase 2 design. Longitudinal research blood, tissue, and microbiome samples will be collected along with neurocognitive assessments and quality of life surveys.

RESULTS

This study is actively enrolling. Eight of planned 30 subjects have been treated. At a median follow-up of 8 months, IC response was seen in 43% of patients. Grade 3 TRAEs occurred in 12% of patients with no new safety signals.
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