Pediatric CancerNCT03126643
Expanded Access to Nivolumab (Opdivo)
A study testing Nivolumab in people with Pediatric Cancer, run by Bristol-Myers Squibb.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Nivolumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
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.
About this study
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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Nivolumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo, BMS-936558
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126643
- Sponsor's protocol ID
- EAP-01-CA209
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2017
- Last updated
- 29 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Nivolumab (Opdivo)
- ClinicalTrials.gov ID
- NCT03126643
- Acronym / sponsor ID
- EAP-01-CA209
- Conditions
- Pediatric Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo, BMS-936558Opdivo (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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Information for Early Patient Access to Investigational DrugsLink provided by the sponsor.
Related trials for Pediatric Cancer
RecruitingObservational study
Menin Inhibitors in Pediatric Relapsed or Refractory Acute Leukemia
Acute Leukemia, Relapsed or Refractory Pediatric Leukemia
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Recruiting
Hospital Based Continuous Patient Monitoring System
Trauma, Appendectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab in people with Pediatric Cancer, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.