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Checkpoint Inhibitor

Nivolumab + Ipilimumab +/- SBRT for Skin Cancer

Phase 2
Waitlist Available
Led By Evan Wuthrick, M.D
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2
Must have at least 2 distinct lesions as documented by a complete physical examination or imaging studies within 4 weeks prior to randomization. Imaging studies must include a diagnostic CT scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions)
Must not have
History of Grade 3 toxicity or use of infliximab with prior immunotherapy
Patients with active brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Summary

This trial will test a new cancer treatment of two drugs plus or minus radiation.

Who is the study for?
This trial is for adults with Merkel Cell Carcinoma that's measurable, not removed by surgery or at stage IV. They should be fairly active (ECOG <2), have two distinct lesions, and can have had prior treatments if there's still measurable disease. Excluded are those with brain metastasis, autoimmune diseases, recent immunosuppressants use, or certain cancer histories.
What is being tested?
The study tests the combination of Nivolumab and Ipilimumab immune-boosting drugs with/without SBRT radiation to see how well they work against skin cancer cells. Participants will be randomly assigned to receive either both drugs or the drugs plus radiation.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver or lungs, skin issues such as rash or itching, hormone gland problems (like thyroid dysfunction), fatigue, nausea, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities without help.
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I have at least 2 distinct cancer lesions, confirmed by recent scans.
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I am 18 years old or older.
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My disease can be seen and measured on scans or physical exams.
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My Merkel cell carcinoma is advanced and cannot be removed by surgery, with at least 2 distinct tumors.
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I can provide a tissue sample from my tumor for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced severe side effects or used infliximab with past cancer treatments.
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I have active cancer spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best Overall Response
Secondary study objectives
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Design

2Treatment groups
Active Control
Group I: Arm A: Nivolumab + IpilimumabActive Control2 Interventions
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Group II: Arm B: Nivolumab + Ipilimumab + SBRTActive Control3 Interventions
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.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,490 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,595 Total Patients Enrolled
Evan Wuthrick, M.DPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03071406 — Phase 2
Neuroendocrine Carcinoma Research Study Groups: Arm A: Nivolumab + Ipilimumab, Arm B: Nivolumab + Ipilimumab + SBRT
Neuroendocrine Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03071406 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03071406 — Phase 2
~6 spots leftby Sep 2025
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