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Pembrolizumab for Cancer Post-Stem Cell Transplant
Study Summary
This trial is designed to study the safety of giving the drug pembrolizumab to people who have had a stem cell transplant to treat their cancer. Pembrolizumab will be given at a fixed dose of 200 mg IV (into a vein) every 3 weeks. Up to 26 patients will be enrolled in this trial.
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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- My cancer has not spread to my brain or spinal cord.I haven't had cancer treatment in the last 2 weeks and have recovered from any side effects.I have never needed steroids for lung inflammation and don't have active lung or colon inflammation.I have never had severe acute GVHD or any chronic GVHD.I do not have any active cancer other than my current diagnosis, except for treated skin cancer or cervical cancer.I am not pregnant, breastfeeding, nor planning to become pregnant or father a child during the trial and for 120 days after.I am 18 years old or older.I can carry out all my usual activities without help.I haven't taken steroids or immunosuppressants in the last 2 weeks.I haven't taken any cancer antibody treatments in the last 4 weeks and have recovered from any previous cancer treatment side effects.I have not had a donor lymphocyte infusion in the last 8 weeks.I do not have a history of serious heart conditions.I do not have an infection that needs IV antibiotics.My cancer has returned after a stem cell transplant.My B cell lymphoma has a measurable tumor larger than 15mm long and 10mm wide.I haven't used any experimental treatments or devices in the last 4 weeks.My kidney function, measured by creatinine or GFR, is within the normal range.I had a stem cell transplant from a donor more than 90 days ago.I have never had Veno-Occlusive Disease (VOD).My organ functions are within normal ranges as required.I have taken a pregnancy test within the last 72 hours and it was negative.I am using or willing to use two forms of birth control or abstain from sex during the study.I agree to use or continue using birth control until 4 months after my last dose of the study medicine.I have a detailed record of my medical history, current health conditions, and any treatments I've had.I do not have HIV.I have AML, MDS, or B cell lymphomas that came back after a stem cell transplant from a matched donor.I have not received a live vaccine in the last 30 days.I haven't taken medication for an autoimmune disease in the last 2 years.I haven't taken any immunosuppressive drugs for at least 2 weeks, except for low-dose steroids.I have signed the consent form for this study.My liver function tests are within the required range.
- Group 1: Pembrolizumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
How many individuals are being treated as part of this experiment?
"Affirmative. Clinicaltrials.gov hosts data that confirms the recruitment of 26 patients from one medical centre for this trial, which was originally posted on March 7th 2017 and last updated June 29th 2021."
What medical conditions has Pembrolizumab been proven to be effective in alleviating?
"Pembrolizumab is routinely administered as a treatment for malignant neoplasms. It has also been utilized to address cases of unresectable melanoma, microsatellite instability-high diseases, and situations where chemotherapy fails to stop disease progression."
Are there any available openings in this medical research project?
"According to the public record on ClinicalTrials.gov, this clinical trial is actively recruiting participants. The listing was initially posted in March of 2017 with a final edit taking place at the end of June 2021."
Could you provide information on other research pertaining to Pembrolizumab?
"At present, there are 962 trials utilising Pembrolizumab. Of these studies, 122 have moved into Phase 3 testing. The majority of research is based in Houston but the drug can be accessed at thirty-five thousand seven hundred and sixty five other locations worldwide."
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