Nivolumab + Ipilimumab +/- SBRT for Skin Cancer

Recruiting at 1 trial location

Overseen By Mia Aoki

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Infliximab, Corticosteroids

Disqualifiers: Active brain metastasis, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or unacceptable toxicity

50 Participants Needed

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.

Research Team

Evan Wuthrick, M.D

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

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.

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

Exclusion Criteria

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

I have an autoimmune disease but it's either type I diabetes, thyroid issues needing only hormone replacement, or skin conditions not needing systemic treatment.

I am not on high-dose steroids or other immune-weakening drugs for the past 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab every 2 weeks and Ipilimumab every 6 weeks, with or without Stereotactic Body Radiation Therapy (SBRT) at the start of week 2

Until progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab
• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview 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.

Participant Groups

Group I: Arm A: Nivolumab + Ipilimumab Active Control 2 Interventions

Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.

Group II: Arm B: Nivolumab + Ipilimumab + SBRT Active Control 3 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:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania