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Expanded Access to Nivolumab (Opdivo)

NCT ID: NCT03126643

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-936558

Eligibility Criteria

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Inclusion Criteria

* 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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine.html

Information for Early Patient Access to Investigational Drugs

Other Identifiers

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EAP-01-CA209

Identifier Type: -

Identifier Source: org_study_id