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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Best Overall Response
Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).
Time frame: Up to 18 months
Progression Free Survival (PFS)
Median Progression Free Survival with 95% Confidence Interval. Progression is defined as progressive tumor lesions per immune-related Response Evaluation in Solid Tumors (irRECIST) definition, or appearance of one or more new Merkel cell carcinoma lesions, which can be local or distant in location from the irradiated lesions.
Time frame: up to 28 months
Overall Survival (OS)
Median Overall Survival with 95% Confidence Interval. The length of time from the start of treatment until death from any cause.
Time frame: Up to 30 months
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