drugset / Trial / NCT02239900
Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these treatments given consecutively will also be studied. This is an investigational study. SBRT is FDA approved for the control of metastatic and primary tumors. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma that cannot be removed with surgery. The use of SBRT with ipilimumab is investigational. The study doctor can explain how the study drug is designed to work. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Timeline
- Start
- 2014-08-26
- Primary completion
- 2019-10-25
- Completion
- 2019-10-25
Publications
- He K, Hong DS, Tang C, Sezen D, Cox L, Maleki A, Bertolet G, Nguyen QN, Comeaux NI, Schuda L, Chen D, Welsh JW. Five-year overall survival with ipilimumab and stereotactic ablative radiotherapy for metastatic disease. Radiother Oncol. 2023 Jun;183:109618. doi: 10.1016/j.radonc.2023.109618. Epub 2023 Mar 13.
- Chen D, Menon H, Verma V, Guo C, Ramapriyan R, Barsoumian H, Younes A, Hu Y, Wasley M, Cortez MA, Welsh J. Response and outcomes after anti-CTLA4 versus anti-PD1 combined with stereotactic body radiation therapy for metastatic non-small cell lung cancer: retrospective analysis of two single-institution prospective trials. J Immunother Cancer. 2020 Jan;8(1):e000492. doi: 10.1136/jitc-2019-000492.
- Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |