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Nivolumab for Bladder Cancer (NEXT Trial)
NEXT Trial Summary
This trial is testing a new cancer treatment combining chemotherapy, radiation, and immunotherapy. The goal is to see if this new treatment can help people with bladder cancer live cancer-free for longer.
NEXT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNEXT Trial Timeline
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 • NCT02041533NEXT Trial Design
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Who is running the clinical trial?
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- I had surgery to remove part of my bladder due to cancer before starting chemoradiation.I am using two birth control methods or am not able to have children, and will continue for 5 months after the study.My cancer originates from the bladder, urethra, or lower ureter.I've had chemotherapy combined with radiation therapy targeting the pelvic area.I may or may not have had platinum-based chemotherapy before chemoradiation.You have a known or suspected autoimmune disease that is currently active.I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.My cancer has spread to areas not treated by radiation.I have inflammatory bowel disease.I can perform daily activities with minimal assistance.I am 18 years old or older.All my side effects from cancer treatment have mostly gone, except for possible kidney issues, nerve pain, hearing loss, hair loss, or tiredness.My blood tests show normal white blood cells, neutrophils, and hemoglobin levels.My kidneys are functioning well enough, as per a specific test.I have taken a pregnancy test within the last 72 hours and it was negative.Your doctor thinks you may have less than 2 years to live.I am not pregnant, willing to use contraception, and if breastfeeding, I can stop during the study.I can begin the study treatment within 90 days after finishing chemoradiation.I agree to use birth control from the start of the study until 7 months after it ends.I have another cancer that is getting worse or needs treatment.My bladder cancer is at a stage where surgery to remove it isn't an option for me.Your liver tests show normal levels of bilirubin and aminotransferase.You have a long-term weakened immune system, HIV, or active Hepatitis B or C infection.My bladder cancer has spread too widely to be targeted by a focused radiation treatment.
- 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.
- Group 1: Nivolumab, all patients
Frequently Asked Questions
Are there any open vacancies for this research project?
"This study, which was first advertised on clinicaltrials.gov on 7/10/2017, is currently seeking participants for the trial."
What are Nivolumab's most common indications?
"Nivolumab can be used to help fight various types of cancer such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Does Nivolumab have a lot of negative side effects?
"Nivolumab's safety is estimated to be a 2. Although there is some data suggesting it is safe, as this is only a Phase 2 trial, there is no evidence yet that the medication is effective."
Has anything like this been done before?
"Nivolumab clinical trials began a decade ago in 2010. Medarex, the pharmaceutical company sponsoring the research, recruited 127 patients for their initial Phase 1 trial. Nivolumab was approved for use after this first study and there are now747 active studies involving this drug taking place across 2347 cities and 50 countries."
So far, how many people have signed up to participate in this research project?
"That is correct, the information available on clinicaltrials.gov indicates that this study wants more participants. The trial was first advertised on 7/10/2017 and was updated as recently as 7/19/2022. They are seeking a total of 28 individuals from 2 distinct locations."
What does the research say about Nivolumab's efficacy?
"There are currently 747 ongoing studies involving Nivolumab, with the majority of them being Phase 3 trials. Most of these clinical investigations are happening in Basel, BE; however, there are a total of 40325 locations where Nivolumab trials are taking place."
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