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Expanded Access to Nivolumab (Opdivo)

Expanded Access to Nivolumab (Opdivo)

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03126643
Enrollment
Unknown
Registered
2017-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

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.

Interventions

BIOLOGICALNivolumab

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.

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years

Inclusion 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026