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Bristol-Myers Squibb

Expanded Access to Nivolumab (Opdivo)

Official Title: 
Expanded Access to Nivolumab (Opdivo)
Brief Summary: 
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.
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.

Available
EA Type
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
Other Name: 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 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.

Eligibility Gender: 
All
Eligibility Age: 
Maximum: 17 Years
Contacts: 

Bristol-Myers Squibb, Study Director
Please Email:
Clinical.Trials@BMS.com

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Bristol-Myers Squibb
EA Number: 
MeSH Terms: 
Nivolumab
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.