Nivolumab Safety for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is Nivolumab safe for humans?
Nivolumab, also known as Opdivo, is generally considered safe but can cause immune-related side effects, such as inflammation in various organs, and rare but serious blood-related issues. It has been associated with diabetic ketoacidosis (a serious diabetes complication) and other immune reactions, especially when combined with other drugs like ipilimumab.12345
How does the drug nivolumab differ from other cancer treatments?
What data supports the effectiveness of the drug Nivolumab (Opdivo) for cancer treatment?
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 cancer patients who have previously been treated with Nivolumab, either completed the treatment, experienced progression during it, or stopped due to side effects. They can join for long-term safety follow-up but not receive further Nivolumab unless deemed beneficial by the original study criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various experimental cancer therapies including Nivolumab monotherapy and combinations with other drugs
Follow-up
Participants are monitored for long-term safety and effectiveness of the treatments
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
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
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Clovis Oncology, Inc.
Industry Sponsor
Patrick J. Mahaffy
Clovis Oncology, Inc.
Chief Executive Officer since 2009
BA from Haverford College, MBA from Columbia University
Lindsey Rolfe
Clovis Oncology, Inc.
Chief Medical Officer since 2015
Specialist accreditation in pharmaceutical medicine