drugset / Trial / NCT03807765
Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases
Phase 1
Completed
14 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is to find out if administration of stereotactic radiosurgery (SRS) given after Nivolumab will improve overall response rate/anti-tumor activity in patients with metastatic breast cancer with brain metastases.
Timeline
- Start
- 2019-01-30
- Primary completion
- 2020-09-08
- Completion
- 2025-03-18
Publications
- Ahmed KA, Kim Y, Kim S, Wang MH, DeJesus M, Arrington JA, Soyano AE, Armaghani AJ, Costa RLB, Loftus LS, Rosa M, Caudell JJ, Diaz R, Etame AB, Tran ND, Soliman H, Czerniecki BJ, Forsyth PA, Yu HM, Han HS. Nivolumab and stereotactic radiosurgery for patients with breast cancer brain metastases: long-term results and biomarker analysis from a non-randomized, open-label, phase Ib study. J Immunother Cancer. 2025 Apr 28;13(4):e011432. doi: 10.1136/jitc-2024-011432.
- Ahmed KA, Kim Y, Arrington JA, Kim S, DeJesus M, Soyano AE, Armaghani AJ, Costa RLB, Khong HT, Loftus LS, Rosa M, Caudell JJ, Diaz R, Robinson TJ, Etame AB, Tran ND, Sahebjam S, Soliman HH, Czerniecki BJ, Forsyth PA, Yu HM, Han HS. Nivolumab and Stereotactic Radiosurgery for Patients With Breast Cancer Brain Metastases: A Nonrandomized, Open-Label Phase 1b Study. Adv Radiat Oncol. 2021 Sep 11;6(6):100798. doi: 10.1016/j.adro.2021.100798. eCollection 2021 Nov-Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |