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Radioactive Agent
Nivolumab for Neuroblastoma (MiniVan Trial)
Phase 1
Recruiting
Led By Juliet Gray
Research Sponsored by University Hospital Southampton NHS Foundation Trust
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
MiniVan Trial Summary
This trialis researching a promising combination of drugs to improve outcome in neuroblastoma, a type of cancer in children. It will take place in 4 hospitals over 2 yrs, assessing safety & efficacy.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of combining an anti-GD2 antibody (standard treatment) with two drugs: 131-I mIBG (a radioactive compound) and Nivolumab (an immune system-boosting drug). It's an adaptive trial in three cohorts, gradually increasing doses if safe, across hospitals in the UK, Germany, and USA.See study design
What are the potential side effects?
Potential side effects include inflammation from immune responses due to Nivolumab, radiation-related effects from mIBG therapy such as nausea or thyroid damage, allergic reactions to Dinutuximab Beta antibodies including skin rash or fever. Each child's experience may vary.
MiniVan Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nivolumab
Secondary outcome measures
Anti-tumour response in patients with measureable disease as measured by immunocytology, MIBG, CT and/or MRI in patients receiving 131-I-MIBG, ch14.18/CHO and Nivolumab in patients with relapsed and refractory high risk neuroblastoma
KIR/KIR-Ligand genotype, FcγR genotype
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
MiniVan Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
The dose and schedule of 131-I mIBG will be constant, and the doses of ch14.18/ CHO and Nivolumab determined by cohort:
Cohort I: 3 mg/kg Nivolumab (100% adult dose). No ch14.18/CHO. (3-6 patients)
Cohort II: 50mg/m2/cycle ch14.18/CHO (50% established Long Term Intervention (LTI) dose) and 3 mg/kg Nivolumab (100% adult dose) (3-6 patients)
Cohort III: 100mg/m2/cycle ch14.18/CHO (100% established LTI dose) and 3 mg/kg Nivolumab (100% adult dose) (initial 3-6 patients, expanded to 15 patient cohort if tolerated)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University Hospital Southampton NHS Foundation TrustLead Sponsor
203 Previous Clinical Trials
134,276 Total Patients Enrolled
1 Trials studying Neuroblastoma
288 Patients Enrolled for Neuroblastoma
University College London HospitalsOTHER
194 Previous Clinical Trials
1,171,558 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,193 Previous Clinical Trials
3,161,895 Total Patients Enrolled
4 Trials studying Neuroblastoma
148 Patients Enrolled for Neuroblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You can participate in the study if you have a seizure disorder, but only if your seizures are under control with medication.You have symptoms of heart failure or an irregular heartbeat that is not under control.You have a serious neurological problem or severe peripheral neuropathy.You have noticeable fluid buildup around your lungs that is causing symptoms.You need or will likely need medications that weaken your immune system, like corticosteroids.You have neuroblastoma that has come back or has not responded well to previous treatment and is considered high risk according to the INRG criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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