A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma
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.
Primary: To compare the efficacy, as measured by objective response rate (ORR), provided by nivolumab plus ipilimumab with or without SBRT in subjects with metastatic Merkel cell carcinoma. Secondary: To compare the progression free survival (PFS) of nivolumab and ipilimumab versus SBRT plus nivolumab and ipilimumab in subjects with metastatic Merkel cell carcinoma. To compare the overall survival (OS) of nivolumab and ipilimumab versus SBRT plus nivolumab and ipilimumab in subjects with metastatic Merkel cell carcinoma. To evaluate the local control of irradiated tumor provided by SBRT in combination with nivolumab and ipilimumab. To assess the overall safety and tolerability of of nivolumab and ipilimumab versus SBRT plus nivolumab and ipilimumab in subjects with metastatic Merkel cell carcinoma. To evaluate whether PD-L1 expression is a predictive biomarker for ORR. To evaluate the Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Yervoy (Ipilimumab)
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.