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Study Summary
This trial is testing whether nivolumab is a safe and effective treatment for a type of cancer called primary central nervous system lymphoma.
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 • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- I do not have active lung inflammation.I am 65 years old or older.I am considered not suitable for certain brain or stem cell treatments due to my age, physical condition, or doctor's advice.You are expected to live for at least 3 more months.I have an autoimmune disease but it's under control or not expected to worsen.I do not have active hepatitis B or C, or it is resolved with undetectable HBV DNA.I am a woman who can have children and have a recent negative pregnancy test.I haven't had any active cancer in the last 5 years, except for minor skin cancers or treated cancers with low risk of coming back.I have recovered from side effects of my previous treatment, except for hair loss.I haven't taken any experimental drugs in the last 28 days.My lymphoma is confirmed to be CD20 positive.My kidney function is within the normal range.I have only had specific chemotherapy for my brain lymphoma, but steroids are okay.My lymphoma is present in my body but not in my brain.I have no active infections and haven't needed antibiotics for over 48 hours.I do not have any severe illnesses that my doctor thinks could interfere with the study.My recent tests show my organs are functioning well.I understand and can follow the study's procedures.My eyes have not been affected by my condition, as confirmed by a doctor.I've completed at least 2 cycles of strong methotrexate chemotherapy without my cancer getting worse.I can care for myself but may not be able to do heavy physical work.I have not had major surgery or radiotherapy in the last 14 days.My cancer was measurable by scans before starting my first treatment.
- Group 1: Stage 1
- Group 2: Stage 2
- 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 still slots for participants in this clinical experiment?
"Affirmative, the posted information on clinicaltrials.gov implies that this trial is presently recruiting participants. This study was initially advertised on July 25th 2019 and recently updated November 16th 2022. It requires 20 patients to be recruited from 4 distinct sites."
What is the participant enrollment rate for this research project?
"To successfully carry out this trial, the sponsor (Bristol-Myers Squibb) requires 20 eligible participants. The study is being managed from multiple locations including UNC Hospitals located in Chapel Hill and Levine Cancer Institute based in Charlotte."
How many establishments are overseeing this research endeavor?
"There are several sites currently enrolling patients in this trial, such as the UNC Hospitals, The University of North carolina at Chapel Hill in Chapel Hill, Levine Cancer Institute in Charlotte and The University of Texas - MD Anderson Cancer Centerin Houston."
Has there ever been a comparable trial of this type previously conducted?
"Nivolumab's first trial was conducted in 2012, headed by Ono Pharmaceutical Co. Ltd., and included 659 participants. After the successful completion of Phase 1 & 2 trials, Nivolumab has been studied extensively across 2356 urban centres located within 49 nations -- with 717 clinical studies currently running."
Have there been any prior investigations into Nivolumab's efficacy?
"Nivolumab was first evaluated in 2012 at a Local Institution, with 252 trials completed since then. Currently, 717 active investigations are underway across the world, chiefly occurring out of Chapel Hill, North carolina."
How is Nivolumab usually administered to treat medical conditions?
"Nivolumab is frequently prescribed to combat malignant neoplasms. It has also been used with some success in the management of unresectable melanoma, squamous cell carcinomas, and metastatic esophageal adenocarcinoma."
Is Nivolumab hazardous for patients?
"Our team of scientists at Power ranked the safety profile of Nivolumab as a 1 due to its current status in Phase 1 clinical trials, indicating only limited data regarding efficacy and security."
What primary goals are investigators hoping to accomplish with this research study?
"The primary goal of this research is to gauge the efficacy of Nivolumab. In order to do so, up to 6 participants will be carefully monitored for potential adverse reactions. Secondary objectives include measuring overall survival (defined as time from enrollment until death), progression-free survival (time between enrollment and first sign of progressive disease or mortality) and response rates via International Criteria for Primary Central Nervous System Lymphoma standards."
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