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Nivolumab + Ipilimumab +/- SBRT for Skin Cancer
Study Summary
This trial will test a new cancer treatment of two drugs plus or minus radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have experienced severe side effects or used infliximab with past cancer treatments.I can do most of my daily activities without help.I have at least 2 distinct cancer lesions, confirmed by recent scans.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.I am 18 years old or older.My disease can be seen and measured on scans or physical exams.I've had chemotherapy or immunotherapy and my cancer can still be measured.I have had radiation therapy but still have measurable cancer.My Merkel cell carcinoma is advanced and cannot be removed by surgery, with at least 2 distinct tumors.I have active cancer spread to my brain.I can provide a tissue sample from my tumor for testing.I have no history of cancer except for certain skin cancers, CLL, or cancers I've fully recovered from.
- Group 1: Arm A: Nivolumab + Ipilimumab
- Group 2: Arm B: Nivolumab + Ipilimumab + SBRT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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