NCT03071406

Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma

A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Merkel Cell Carcinoma
• Skin Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
DRUG	Ipilimumab	Ipilimumab 1 mg/kg/dose IV q6 weeks.
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Stereotactic Body Radiation Therapy 24Gy in 3 fractions.

Timeline

• Start date: 2017-03-14
• Primary completion: 2022-04-06
• Completion: 2026-09-19
• First posted: 2017-03-06
• Last updated: 2026-03-11
• Results posted: 2023-05-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study