CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 50 enrolled
Drug / intervention
Nivolumab +2 moredrug
Likely dose
Nivolumab 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03071406
NCT03071406Phase 2Active
CompareCT.gov

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

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Mar 6, 2017·Updated Mar 11, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Merkel Cell Carcinoma and Skin Cancer. Active but no longer recruiting, targeting 50 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMerkel Cell Carcinoma, Skin Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2Active
2017201820192020202120222023202420252026
First PostedMar 6, 2017
Enrollment StartMar 14, 2017
Primary CompletionApr 6, 2022
Study CompletionSep 19, 2026
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.3 years ago

Interventions

Nivolumabdrug

Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.

Ipilimumabdrug

Ipilimumab 1 mg/kg/dose IV q6 weeks.

Stereotactic Body Radiation Therapy (SBRT)radiation

Stereotactic Body Radiation Therapy 24Gy in 3 fractions.