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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I've had chemotherapy or immunotherapy and my cancer can still be measured.
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I have had radiation therapy but still have measurable cancer.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response
Secondary outcome measures
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
537 Previous Clinical Trials
134,941 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,486 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence exists to demonstrate the security of using Arm B: Nivolumab + Ipilimumab + SBRT for patients?

"Through an evaluation from our experts at Power, Arm B: Nivolumab + Ipilimumab + SBRT was assigned a score of 2. This is because Phase 2 trials have some evidence to suggest safety but lack any definitive proof of effectiveness."

Answered by AI

Have any other research endeavors explored the combined efficacy of Nivolumab, Ipilimumab, and SBRT?

"Currently, 765 clinical trials for Arm B: Nivolumab + Ipilimumab + SBRT are underway. Of this total, 86 studies have progressed to Phase 3 trial status. Primarily situated in Pittsburgh, Pennsylvania, the research related to this treatment regimen is taking place at a staggering 42707 sites worldwide."

Answered by AI

How many participants have enrolled in this experiment thus far?

"This clinical trial is no longer accepting applicants. It was initially posted on March 14th 2017 and the most recent update to its listing occurred November 11th 2022. Alternatively, there are currently 2594 medical trials recruiting patients with skin cancer as well as 765 studies actively enrolling participants for Arm B: Nivolumab + Ipilimumab + SBRT treatment plans."

Answered by AI

What conditions typically necessitate the combination of Nivolumab, Ipilimumab and SBRT as a course of treatment?

"The combination of Nivolumab, Ipilimumab, and SBRT (Arm B) is frequently used for cases involving anti-angiogenic therapy. It has also seen to be effective at treating malignancies such as melanoma or squamous cell carcinoma that are unresectable."

Answered by AI

Are new participants being admitted to this clinical research?

"This clinical trial is no longer actively recruiting. It was initially posted on March 14th 2017 and last edited November 11th 2022. If you are searching for other trials, there are currently 2594 studies hunting for participants with skin cancer as well as 765 studies seeking volunteers to take part in Arm B: Nivolumab + Ipilimumab + SBRT."

Answered by AI
~6 spots leftby Mar 2025