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Pre- and Post-Surgery Pembrolizumab for Melanoma
Study Summary
This trial is testing whether giving the immunotherapy drug pembrolizumab before and after surgery is better than giving it just after surgery for treating patients with high-risk 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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I can have surgery or radiation to remove any tiny cancer remains before starting additional treatment.I've had radiation or surgery for cancer, and any side effects are now mild.I have had a brain scan within the last 42 days.I have had cancer before, but it doesn't need current treatment.I am HIV positive with stable health, CD4 count >= 350, and viral load < 25,000 IU/ml.I will register for the next step of the trial at least 17 days before my surgery.My melanoma is at stage III or IV and can be surgically removed, but I don't have brain metastases.I do not have an infection that needs treatment with medication.I have melanoma and haven't had immunotherapy or neoadjuvant treatment for it.Your white blood cell count is at least 1,500 cells per microliter.Your alkaline phosphatase level must be within a certain range before you can join the study.I've had a full check-up and scans showing no signs of cancer recently.I agree to provide tissue samples for testing after receiving pre-surgery treatment.My cancer's status has been checked with a physical exam and specific scans within the last 42 days.I can take care of myself but might not be able to do heavy physical work.My melanoma was confirmed at its first appearance or when it spread.My melanoma is confirmed to be at least stage IIIB through biopsy.My kidney function is good, with a creatinine clearance rate over 30 mL/min.My doctors agree I am healthy enough for surgery.I registered for step 3 within 84 days after my surgery.I've had surgery to remove my cancer and recent scans show no signs of cancer.I have not had an R2 resection.I had surgery to completely remove my melanoma before joining Step 3.Your hemoglobin level is at least 10 grams per deciliter within 42 days before starting the study.Your platelet count is at least 100,000 per microliter within the 42 days before starting the study.You should not have an active infection of hepatitis B or hepatitis C before starting the study.Your liver enzymes (AST and ALT) should not be more than two times the upper limit of normal.I haven't needed treatment for an autoimmune disease in the last 2 years.You need to have had a test for lactate dehydrogenase (LDH) within 42 days before starting the trial.My cancer has spread to multiple lymph nodes but I am still eligible.I've had the required scans within the last 42 to 49 days before my planned surgery.I do not have any visible cancer left after surgery.I am willing to provide tissue samples from my surgery for research.I have never needed steroids for non-infectious lung inflammation.Your bilirubin level should be below a certain number, unless you have Gilbert's syndrome, in which case it can be slightly higher.I have not received any live vaccines in the last 42 days.I am not planning to undergo any other cancer treatments while on this trial.
- Group 1: Arm I (adjuvant pembrolizumab)
- Group 2: Arm II (adjuvant and 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 other examples of Pembrolizumab's efficacy?
"Pembrolizumab is being trialed in 1000 different ongoing clinical studies. 122 of those are large-scale Phase 3 trials. Although many of the Pembrolizumab trials originate out of Houston, Texas, there are 36030 locations worldwide conducting research on this treatment."
Are participants still being recruited for this research?
"This study is not recruiting at this moment. The listing for the trial was first posted on December 6th, 2018 and updated most recently on September 23rd, 2022. Other melanoma trials 848 are currently looking for patients while 1000 other Pembrolizumab studies are actively enrolling participants."
Has Pembrolizumab received the green light from the FDA?
"Pembrolizumab has not been proven effective yet, however, there is some evidence that it is safe. Consequently, our team at Power awarded it a 2."
What are the primary indications for Pembrolizumab?
"Pembrolizumab is an immunotherapy treatment that can be used for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."
How many people are being given this experimental medication?
"No, this study concluded its search for participants on September 23rd, 2022. The trial was first posted December 6th, 2018. If you are looking for other melanoma trials, 848 are actively enrolling patients while 1,000 trials are still recruiting for Pembrolizumab treatment."
At how many different hospitals is this research project being conducted?
"You can find a full list of the 100 clinical trial sites on our website. The locations are spread out across Saint George, Burnsville, Hibbing and many other places. To limit travel, make sure to choose a site that is close to your location."
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