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ACTIVE NOT RECRUITING
NCT03071406
PHASE2

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

Interventions

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.

Locations (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States