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Binimetinib + Nivolumab for Skin Cancer
Study Summary
This trial studies how well binimetinib and nivolumab work in treating patients with melanoma. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.
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.Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT02928224Trial Design
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- I cannot swallow or keep down the medication.I do not have a history of eye blood vessel blockage or diseases that increase its risk.I am allergic to binimetinib or its ingredients.I haven't had major surgery in the last 6 weeks or still recovering from one.I experienced severe side effects from my first anti-PD-1 cancer treatment.Your white blood cell count is at least 2,000 per cubic millimeter.Your hemoglobin level is at least 8.0 grams per deciliter.I had radiotherapy more than 14 days ago or have recovered from its side effects.You are being held against your will for treatment of a psychiatric or physical illness.I have an autoimmune disease but it's controlled or minor like type I diabetes, hypothyroidism, vitiligo, psoriasis, or alopecia.Your albumin levels are equal to or greater than 2.5 grams per deciliter.I have a muscle disorder that increases my CK levels.I am taking more than 10 mg of prednisone or its equivalent daily for another condition.I have not had a stroke or significant blood clot in the last 3 months.My tumor does not have the V600BRAF mutation.I agree to use effective birth control or abstain from sex during the study and for 5 months after.I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.My melanoma cannot be removed by surgery and has spread.I haven't had cancer treatment or experimental drugs in the last 14 days.I have been cancer-free for 2 years, except for certain skin or superficial cancers.I am unable to understand and agree to the study's details.Women who could become pregnant must have a negative pregnancy test before starting the study drug.My brain metastases are stable, not requiring steroids, and I haven't had radiation in the last 28 days.My cancer did not respond to previous immunotherapy treatments.Your bilirubin levels must be within a certain range, unless you have a condition called Gilbert's disease, in which case it must be within a higher range.My heart pumps well, as shown by a recent heart scan.I am not currently on any experimental or standard cancer treatments.I have recovered from the side effects of my previous cancer treatment.My cancer can be measured by scans or visible and measured with a picture.Your platelet count is at least 75,000 per cubic millimeter.I cannot have a tumor biopsy due to bleeding disorders or severe scarring.I do not have serious heart problems.I have previously been treated with a MEK inhibitor.I have had treatments for cancer that has spread, not counting initial or maintenance therapy.I have or had lung inflammation that needed steroids.Your liver enzymes (AST and ALT) are not more than 3 times the normal limit, or 5 times the normal limit if you have cancer that has spread to the liver.I am not pregnant or breastfeeding.I have or had inflammatory bowel disease.I am 18 years old or older.I am fully active or can carry out light work.I agree to use contraception or abstain from sex for 5 months after my last treatment dose.I do not have any stomach or bowel problems that could affect how a medicine works in my body.I can have a biopsy on my cancer.Your kidney function, as measured by a blood test, is within a certain range.Your absolute neutrophil count is at least 1,500 per cubic millimeter.
- Group 1: Treatment (binimetinib, nivolumab)
- 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
Did the FDA give its okay to market Binimetinib?
"There is some data indicating that Binimetinib is safe, but it has not been proven effective yet. Therefore, it received a score of 2."
What disease does Binimetinib target?
"Binimetinib is most often used as a treatment for cancer, but can also be effective in treating metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."
How many people have signed up to participate in this research project?
"That is correct. The information on clinicaltrials.gov does indicate that this trial needs patients and is currently enrolling them. This specific trial was posted on December 3rd, 2020 and was last updated on May 10th, 2022. Only 28 individuals are needed for this study which is happening at a single location."
Are new participants being sought for this experiment?
"Correct, this clinical trial is looking for participants and was last updated on May 10th, 2022. According to the same source, it was originally posted on December 3rd, 2020."
What are the most similar medical studies to this one involving Binimetinib?
"793 clinical trials are underway to study the efficacy of binimetinib. 84 of these trials have progressed to Phase 3. The majority of these trials originate from Cambridge, England; however, 41455 total locations worldwide are running at least one trial for this treatment option."
What other research projects are like this one in terms of topic and scope?
"Since its initial 2010 study, sponsored by Medarex, there have been 793 live trials for Binimetinib across 2481 cities and 52 countries."
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