Official Title
Expanded Access to Nivolumab (Opdivo)
Brief Summary

At BMS, we work with physicians/investigators to make investigational products availableto patients with life-threatening diseases that have exhausted other treatment optionsand where there is a reasonable expectation of benefit over risk.When contacted by a treating physician, BMS will consider requests for providing earlypatient access to Nivolumab in pediatric patients exhibiting a high mutational load.

Detailed 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.

Approved for marketing
Individual Patients
Pediatric Cancer

Biological: Nivolumab

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody approved by
the US Food and Drug Administration (FDA) on an "accelerated" basis for some types of
cancer. Please contact your physician for more details.
Other Name: Opdivo,BMS-936558

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

- 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.

Eligibility Gender
Eligibility Age
Minimum: N/A ~ Maximum: 17 Years

Bristol-Myers Squibb, Study Director
Bristol-Myers Squibb

Bristol-Myers Squibb
NCT Number
MeSH Terms