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Neoadjuvant PD-1 Blockade for Melanoma
Study Summary
This trial is testing whether giving the drug pembrolizumab before surgery can reduce the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma.
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?
Media Library
- I have not received a live vaccine in the last 30 days.My liver is not functioning well (Child-Pugh score >6).My thyroid condition is not under control.I am 18 years old or older.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.I do not have severe heart conditions like serious arrhythmias, advanced heart failure, or symptomatic heart disease.I am not pregnant and follow the required birth control guidelines.I have another cancer that is getting worse or needs treatment.I am a woman who can have children and I tested positive for pregnancy recently.I am currently being treated for an infection.I haven't had cancer treatment or experimental drugs in the last 4 weeks.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have an active tuberculosis infection.My melanoma cannot be fully removed by surgery according to my surgeon.I agree to follow the study's rules for using birth control.I have an autoimmune disease treated within the last 3 months.You have been diagnosed with HIV.I have a history of Hepatitis B or active Hepatitis C.I have been treated with drugs that target the immune system.I have recovered from any major surgery before starting the study treatment.I have not received blood products or colony stimulating factors in the last 4 weeks.I have or had lung inflammation that needed steroids.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within the required range for the study.My diabetes is not under control.
- Group 1: Neoadjuvant Pembrolizumab
- 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
Are there any available positions for participants in this clinical trial?
"The clinicaltrials.gov website shows that this trial is still looking for volunteers. The listing was created on 7/1/2019 and the most recent update was on 5/17/2022."
What have been the most severe side effects associated with Pembrolizumab?
"While there is some data supporting pembrolizumab's safety, as this drug is still in Phase 2 of clinical trials, its efficacy has yet to be studied."
How many individuals are testing this new medication?
"Affirmative, the clinical trial is currently ongoing and looking for 63 patients from 1 location. The listing was created on July 1st, 2019 and last updated on May 17th, 2022."
Are there any other ongoing or completed studies that use Pembrolizumab?
"There are currently 1000 clinical trials underway related to Pembrolizumab. 122 of those studies are in Phase 3 and the majority are located in Houston, Texas. However, there are a total of 36030 locations running Pembrolizumab studies."
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