Expanded Access to Nivolumab (Opdivo)

Bristol-Myers Squibb (BMS)

Status

Conditions: Pediatric Cancer

Treatments: Biological: Nivolumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03126643

EAP-01-CA209

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.