Nivolumab + Dinutuximab for Neuroblastoma
(MiniVan Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for children with neuroblastoma, a challenging cancer that often affects kids. Researchers aim to determine if adding two new medicines, Nivolumab (also known as Opdivo, an immunotherapy drug) and Dinutuximab Beta Antibodies, to a standard treatment can safely enhance the immune system to fight the cancer more effectively. The trial consists of three stages, each testing different combinations and doses of these drugs to ensure safety and effectiveness. Children whose neuroblastoma has returned or not responded to other treatments might be suitable candidates for this trial, especially if their disease appears on a specific type of imaging test. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are taking systemic corticosteroids or other immunosuppressive agents within 14 days before the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Nivolumab and Dinutuximab Beta have been tested for safety in children with high-risk neuroblastoma. These studies found the combination to be generally well-tolerated. A small study noted that most side effects were manageable and similar to those from other neuroblastoma treatments. Common issues included fever and pain, but these were not severe for most participants.
Nivolumab is already approved for other conditions and is known to be safe for humans. Dinutuximab Beta, used for neuroblastoma, has demonstrated a good safety record when combined with chemotherapy. This suggests that the treatment combination in this trial should be safe for most patients.
Although this trial is in the early stages, with a primary focus on testing safety, existing evidence from other studies is encouraging. Participants will be closely monitored for any side effects to ensure their safety throughout the trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for neuroblastoma, which often include chemotherapy and radiation, the combination of Nivolumab and Dinutuximab offers a novel approach by harnessing the immune system. Nivolumab is a checkpoint inhibitor that helps to unmask cancer cells, allowing the immune system to attack them more effectively. Dinutuximab is an antibody that specifically targets neuroblastoma cells, potentially leading to improved recognition and destruction by the immune system. This dual-action strategy could enhance the body's natural defenses against cancer, offering hope for more effective and targeted treatment options.
What evidence suggests that this trial's treatments could be effective for neuroblastoma?
Research has shown that combining nivolumab and dinutuximab beta yields promising results for treating neuroblastoma, particularly when the cancer returns or continues to grow after treatment. In this trial, participants will receive various combinations of these treatments. In some cases, this combination has led to complete remission (where the cancer disappears) or a very good partial remission (where the cancer shrinks significantly) in patients with relapsed or hard-to-treat neuroblastoma. Dinutuximab beta targets cancer cells as an antibody, while nivolumab boosts the immune system's ability to fight cancer. Together, they appear to improve survival rates. These findings offer hope for children facing this challenging disease.678910
Who Is on the Research Team?
Juliet Gray
Principal Investigator
Consultant Paediatric Oncologist
Are You a Good Fit for This Trial?
This trial is for children with relapsed/refractory high-risk neuroblastoma. They must have a certain type of active disease visible on imaging, be past specific treatments like myeloablative chemotherapy, and meet health criteria such as adequate organ function and performance status. Children with severe prior reactions to similar therapies or certain medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cohort 1 Treatment
Patients receive 131-I MIBG and Nivolumab to assess safety and tolerability
Cohort 2 Treatment
Patients receive 131-I MIBG, Nivolumab, and anti-GD2 to assess safety and tolerability
Cohort 3 Treatment
Patients receive full dose of 131-I MIBG, Nivolumab, and anti-GD2 for expanded safety analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 131-I mIBG
- Dinutuximab Beta Antibodies
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospital Southampton NHS Foundation Trust
Lead Sponsor
University College London Hospitals
Collaborator
University of Wisconsin, Madison
Collaborator
University Hospital Greifswald
Collaborator
Solving Kids' Cancer US/EU
Collaborator
Joining Against Cancer in Kids
Collaborator
The Band of Parents
Collaborator