Expanded Access to Nivolumab (Opdivo)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03126643
BMS offers early access to Nivolumab for pediatric patients with life-threatening diseases and high mutational load, where other treatments have failed. This PD-1 blocking antibody, approved by the FDA for certain cancers, may be requested by physicians for eligible patients. Discuss participation with your doctor and contact BMS for more details.
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Program Overview
At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.
When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.
Description
Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join an early patient access program.
To learn more about early patient access programs, your doctor may contact BMS using the information provided below.
Eligibility Criteria
Specific eligibility criteria must be met for access outside of a clinical trial.
These inclusion criteria include:
- The illness must be serious or life threatening
- There are no other viable options (including approved products or active clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
- Other defined inclusion/exclusion criteria could be applicable.
Get This Program In Your Inbox
You can sign up and apply your patients for this program.