Nivolumab + Ipilimumab +/- SBRT for Skin Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByEvan Wuthrick, M.D

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I can do most of my daily activities without help.

I have at least 2 distinct cancer lesions, confirmed by recent scans.

I am 18 years old or older.

My disease can be seen and measured on scans or physical exams.

My Merkel cell carcinoma is advanced and cannot be removed by surgery, with at least 2 distinct tumors.

I can provide a tissue sample from my tumor for testing.

Exclusion Criteria

I have experienced severe side effects or used infliximab with past cancer treatments.

I have active cancer spread to my brain.

Participant Groups

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.

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.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: