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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met