Nivolumab for Cancer Post-Surgery
(CheckMate 274 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Will I have to stop taking my current medications?
The trial requires that you stop taking corticosteroids or other immunosuppressive medications at least 14 days before starting the study drug.
Is Nivolumab generally safe for humans?
Nivolumab, also known as Opdivo, has been associated with some immune-related side effects like colitis (inflammation of the colon) and other adverse events such as fatigue, diarrhea, and rash. However, it is generally considered to have a manageable safety profile and is better tolerated than some other treatments, like docetaxel, in certain cancer patients.12345
What makes the drug Nivolumab unique for cancer treatment after surgery?
Nivolumab is unique because it is a PD-1 inhibitor, which helps the immune system recognize and attack cancer cells, and it has shown significant benefits in improving survival rates in various cancers, including lung cancer, compared to traditional chemotherapy. It is administered intravenously and is generally better tolerated than some other treatments, making it a novel option for patients post-surgery.36789
What data supports the effectiveness of the drug Nivolumab for cancer post-surgery?
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for patients who've had surgery to remove high-risk invasive urothelial cancer from the bladder, ureter, or renal pelvis. They should be currently free of disease (confirmed by imaging), have not received cisplatin chemotherapy before surgery unless ineligible or refusing further cisplatin treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab or placebo following radical surgery for invasive urothelial cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Placebo
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Ono Pharmaceutical Co. Ltd
Industry Sponsor
Shinji Takai
Ono Pharmaceutical Co. Ltd
Chief Medical Officer since 2023
MD from an unspecified institution
Gyo Sagara
Ono Pharmaceutical Co. Ltd
Chief Executive Officer since 2024
PhD in Pharmaceutical Sciences from Kyoto University