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Pembrolizumab for Pediatric Cancer
Study Summary
This trial is studying a drug (pembrolizumab) to see if it can help to treat children who have cancer that has come back or does not respond to treatment.
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 am currently on medication for an infection.I had an organ transplant or a bone marrow transplant from a donor more than 5 years ago without GVHD symptoms.I am not able to have children or I am using birth control and will not have heterosexual intercourse.I have no progressing cancer except for certain skin cancers or localized cancers that can be cured.I have had pneumonitis treated with steroids or have it now.I have previously been treated with specific immune therapy drugs.I have hepatitis B or C.I have not received a live vaccine in the last 30 days.I have an active tuberculosis infection.My neuroblastoma shows up on a special scan.I have not taken steroids or immunosuppressants in the last 7 days.I haven't had cancer treatment or clinical trial drugs in the last 2 weeks.My cancer is advanced, cannot be cured with standard treatments, and has not responded to or is not suitable for any standard treatments.My organs are working well.I have cancer that has spread to my brain or spinal cord.I have an autoimmune disease but only take replacement therapies like insulin.My cancer is advanced melanoma or PD-L1-positive and has come back or not responded to treatment.I am a woman who can have children and have a recent negative pregnancy test.My organs are functioning well.You have HIV.I have not had radiotherapy in the last 2 weeks.You have a measurable disease according to specific guidelines for determining the size of the disease.I don't have any health issues or allergies that would affect my participation in the study.I am between 6 months and 18 years old.I have had any number of previous treatments.You have had a very strong allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I can provide a tissue sample from a previous or new biopsy.I am mostly active and can do most activities without help, regardless of my age.My cancer affects the brain stem.
- Group 1: rrcHL
- Group 2: MSI-H
- Group 3: Adjuvant Melanoma
- Group 4: Melanoma
- Group 5: Solid Tumors and Other Lymphomas
- Group 6: TMB-H
- 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
Is there an opportunity to join this investigation?
"This study is seeking 370 participants between the age of 6 months and 17 who have been diagnosed with melanoma. In addition to this, potential patients must also adhere to these prerequisites: having incurable cancer that has not responded well or for which no standard therapy exists; access to an archived tissue sample or a newly obtained biopsy; Lansky Play Scale ≥50 (for those aged 16 and under) or Karnofsky score ≥50 (for ages over 16); prior treatment regimens are permitted."
What conditions is Pembrolizumab used to treat?
"Pembrolizumab is frequently prescribed to combat malignant neoplasms, but it can also be taken for unresectable melanoma, microsatellite instability high and the development of disease symptoms after chemotherapy."
Could you elucidate upon the research outcomes of previous experiments involving Pembrolizumab?
"Pembrolizumab was first trialed at City of Hope a decade ago and has since been the subject of 251 successful studies. As it stands, there are 961 ongoing trials with many being conducted in Dallas and Connecticut."
Does the age limit exceed twenty years for participation in this medical experiment?
"This medical trial is seeking participants between the ages of 6 months and 17 years."
How many research facilities are actively participating in this experiment?
"At this moment, 12 clinical sites are recruiting for the trial. These hubs span from Dallas to New Haven and Kirkland among other cities - thus it is advised that prospective participants select a nearby centre in order to minimise their travel needs should they choose to take part."
What are the intended outcomes of this trial?
"This study, which will span up to 2 years and will be evaluated via the Number of Participants Experiencing Adverse Events (AEs), has 3 key objectives. These include: determining Disease Control Rate per RECIST 1.1 Site Assessment for MSIH and TMB-H cohorts respectively; calculating Area Under Conentration Curve (AUC) when administered as monotherapy; and measuring Duration Of Response by RECIST 1.1 Site Evaluation in Advanced Melanoma, Solid Tumors, or Other Lymphoma patients that meet criteria for either Complete Response (CR) or Partial Response (PR)."
Are there still availabilities for participants in this research endeavor?
"Correct. According to clinicaltrials.gov, the trial which began accruing participants on March 18th 2015 is still recruiting patients and was last updated on November 23rd 2022."
What is the total enrolment size for this research experiment?
"To fulfill the specified inclusion criteria, 370 individuals are required to partake in this trial. People can join from multiple locations including Call for Information (Investigational Site 0054) located in Dallas, Connecticut and Call for Information (Investigational Site 0020) based out of New Haven, Quebec."
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