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Protocol No. UW16075

Principal Investigator DeSantes, Kenneth

Phase I

Age Group Both

Scope National

Sponsor Type Industry; Institutional

Title MiNivAN; A Phase 1 study of 131-I mIBG followed by Nivolumab and Dinutuximab beta Antibodies in children with relpased/refractory Neuroblastoma

Objective We want to find out whether three different treatments, 131-I mIBG, Nivolumab and Dinutuximab beta, can be used together to treat neuroblastoma for has not responded well to initial therapy. We want to see if this is a safe treatment and whether they work well together

Treatment
  • Cohort 1 will receive 131-I mIBG and Nivolumab
  • Cohort 2 will receive all three treatments (131-I mIBG, Nivolumab and a lower dose (lower than standard of care) of Dinutuximab beta)
  • Cohort 3 will receive all three treatments (131-I mIBG, Nivolumab and full dose of Dinutuximab beta)

  • Description A Phase I study of 131-I mIBG followed by Nivolumab and Dinutuximab beta Antibody in children with relapsed/refractory Neuroblastoma

    Key Eligibility
  • At study entry patients must be greater than 1 year of age
  • Relapsed or refractory high risk neuroblastoma (as defined by INRG criteria)
  • MIBG avid disease on imaging within 4 weeks to study entry
  • Greater than or equal to 3 months since any myeloablative chemotherapy / stem cell rescue
  • Greater than or equal to 42 days since any other immunotherapy e.g. tumour vaccines. At least 3 half-lives since last dose of any monoclonal antibody therapy
  • Must have a performance status greater or equal 60% (Lansky Score or Karnofsky Performance Scales)
  • Estimated life expectancy greater than or equal to 12 weeks
  • Adequate bone marrow, renal, cardiac,hepatic, lung and pancreatic function as defined by the protocol
  • May have had prior CNS metastasis at point of entry to study, but patients with mIBG avid parenchymal brain lesions will be excluded. All CNS disease must be treated and stable for at least 4 weeks prior to starting trial 131-I mIBG therapy (see section 4). Patients with extra-axial disease (e.g. skull (bone) metastasis that do not invade the dura) may be enrolled providing there is no evidence of brain oedema
  • Must consent to the placement of a central venous line, if one has not already been placed
  • Must have no immediate requirements for palliative chemotherapy, radiotherapy or surgery
  • Can not be pregnant or breast feeding and male and female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Patients with seizure disorders may be enrolled if seizures are well controlled
  • Expression of PD-L1 by tumour is not a pre-requisite
  • Parents or carers willing and able to comply with radiation safety measures needed for 131-I mIBG administration
  • Patient must be judged capable of tolerating isolation procedures associated with 131-I-mIBG therapy
  • Previously received ch14.18 (CHO or SP2/0) will not be excluded unless they have had severe or life threatening toxicity necessitating withdrawal of treatment previously
  • Patients who have had previous 131-I mIBG therapy will not be excluded
  • Autologous stem cells stored and available if needed as defined by the protocol
    EXCLUSION
  • Previously treated with Nivolumab or any other PD-1 or PD-L1 targeting antibodies will be excluded from the study
  • Previous allogeneic stem cell transplant or solid organ transplant
  • Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients receiving systemic corticosteroids (other than physiological replacement) or other immunosuppressive agents within 14 days prior to study entry. Local steroid treatments (e.g. dermal, mucosal, inhaled) are allowed
  • Unable to maintain platelets without transfusion as defined by the protocol
  • HIV or Hepatitis B or C infection
  • Symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance
  • Significant psychiatric disabilities or uncontrolled seizure disorders
  • Active infections, or active peptic ulcers, unless these conditions are corrected or controlled
  • Clinically significant neurologic deficit or objective peripheral neuropathy (Grade greater than 2) are ineligible
  • Clinically significant, symptomatic, pleural effusions. Patients with uncontrolled hypertension

  • Applicable Disease Sites Colon and Rectum; Endocrine cancers; Gastrointestinal cancers, other; Genitourinary cancers, other; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Pancreas; Sarcoma; Stomach; Thyroid

    Status Open

    Participating Institutions UW Hospital and Clinics