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CheckMate901 Trial Summary
This trial will compare the effectiveness of an immunotherapy drug combo vs chemotherapy alone for treating urothelial cancer.
CheckMate901 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
CheckMate901 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2022 Phase 3 trial • 541 Patients • NCT02041533
Awards & Highlights
CheckMate901 Trial Design
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Who is running the clinical trial?
- To learn more about participating in a clinical trial with Bristol-Myers Squibb, please visit www.BMSStudyConnect.com.You have no prior systemic chemotherapy for metastatic or surgically inoperable UC.You have received treatment with certain types of medications that target specific proteins involved in the immune system.Your disease can be treated with local therapy that aims to cure it.You have not received any chemotherapy treatment before for advanced or inoperable bladder cancer.
- Group 1: Arm A: Investigational immunotherapy
- Group 2: Arm B: Standard of care chemotherapy
- Group 3: Arm C: Investigational immunotherapy
- Group 4: Arm D: Standard of care chemotherapy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the research history of Nivolumab?
"The first nivolumab clinical trial was hosted at City of Hope Comprehensive Cancer Center in 1997. A total of 2561 have been completed to date, with 2149 being active as of now. Many of these studies are based out of Halifax, Nova Scotia."
Has Nivolumab received formal recognition by the FDA?
"Nivolumab's safety is supported by both efficacy data from Phase 3 trials as well as multiple rounds of dedicated safety studies--so we've given it a score of 3."
What are the common functions of Nivolumab?
"Nivolumab's usual function is treating urinary bladder cancer, however it can also be effective in combating other forms of cancer such as small cell lung cancer and testicular cancerary bladder cancer, however it can also be effective in combating other forms of cancer such as small cell lung cancer and testicular cancer."
Are investigators still looking for participants for this research project?
"That is correct. The listing on clinicaltrials.gov says that the trial team hopes to enroll 1307 patients at 29 sites around the country. This particular study was first posted on March 24th, 2017 and received its most recent update on November 3rd, 2022."
How many individuals are actively involved in this research project at present?
"In order to carry out this experiment, the researchers need 1307 people that meet a set of specific inclusion criteria. The sponsor, Bristol-Myers Squibb, will be managing the trial from multiple locations including Nova Scotia Health Authority QEII Health Sciences Centre and Local Institution - 0052."
How many different hospitals are participating in this trial?
"With 29 total sites, this clinical trial has many locations across North America including the Nova Scotia Health Authority QEII Health Sciences Centre in Halifax, Local Institution - 0052 in Sherbrooke, and Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center in Milford."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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