Phase II multicenter trial combining nivolumab and radiosurgery for NSCLC and RCC brain metastases.

ABSTRACT:

Background

Anti-PD-1 has activity in brain metastases (BM). This phase II open labeled non-randomized single arm trial examined the safety and efficacy of combining nivolumab with radiosurgery (SRS) in the treatment of patients with BM from non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC).

Methods

This was a multicenter trial (NCT02978404) in which patients diagnosed with NSCLC or RCC, having ≤ 10 cc of un-irradiated BM and no prior immunotherapy were eligible. Nivolumab (240 mg or 480 mg IV) was administered for up to 2 years until progression. SRS (15-21 Gy) to all un-irradiated BM was delivered within 14 days after the first dose of nivolumab. The primary endpoint was intracranial progression free survival (iPFS).

Results

Twenty-six patients (22 NS

SUBMITTER: Wong P 

PROVIDER: S-EPMC10072191 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature