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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03071406
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 14, 2017
Status verified
Feb 2026
Primary completion
Apr 6, 2022
Completion
Sep 19, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Nivolumab + Ipilimumab
    Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
  • Active Comparator: Arm B: Nivolumab + Ipilimumab + SBRT
    Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.

Primary Outcome Measure

Best Overall Response [ Time Frame: Up to 18 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Tampa, FL

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By specialty
OncologySkin cancerDermatology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLOhio State University Comprehensive Cancer Center· Columbus, OH

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