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Expanded Access to Nivolumab (Opdivo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126643
Expanded Access Status : Approved for marketing
First Posted : April 24, 2017
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.


Condition or disease Intervention/treatment
Pediatric Cancer Biological: Nivolumab

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.

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Nivolumab (Opdivo)

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Interventions
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Intervention Details:
  • 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 Names:
    • Opdivo
    • BMS-936558
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126643


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03126643    
Other Study ID Numbers: EAP-01-CA209
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action