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NCT03126643 Clinical Trial

Expanded Access to Nivolumab (Opdivo)

Pediatric Cancer Clinical Trial

Official title:
Expanded Access to Nivolumab (Opdivo)

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03126643
Other study ID # EAP-01-CA209
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date November 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb
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