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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

Tracking Information
First Submitted Date April 18, 2017
First Posted Date April 24, 2017
Last Update Posted Date November 29, 2021
 
Descriptive Information
Brief Title Expanded Access to Nivolumab (Opdivo)
Official Title Expanded Access to Nivolumab (Opdivo)
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.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Pediatric Cancer
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.
Other Names:
  • Opdivo
  • BMS-936558
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03126643
Other Study ID Numbers EAP-01-CA209
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor Bristol-Myers Squibb
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2021