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Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. This study will test an investigational use of nivolumab.
Official title: A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2017-03-14
Completion Date
2026-09-19
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab
Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
Locations (2)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States