Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer

Summary

The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.

Timeline

Start

2017-02-13

Primary completion

2018-10-26

Completion

2023-11-16

Publications

• Perez BA, Kim S, Wang M, Karimi AM, Powell C, Li J, Dilling TJ, Chiappori A, Latifi K, Rose T, Lannon A, MacMillan G, Saller J, Grass GD, Rosenberg S, Gray J, Haura E, Creelan B, Tanvetyanon T, Saltos A, Shafique M, Boyle TA, Schell MJ, Conejo-Garcia JR, Antonia SJ. Prospective Single-Arm Phase 1 and 2 Study: Ipilimumab and Nivolumab With Thoracic Radiation Therapy After Platinum Chemotherapy in Extensive-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):425-435. doi: 10.1016/j.ijrobp.2020.09.031. Epub 2020 Sep 28.

Drugs

Indications