Nivolumab-Ipiliumab: Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers
The main purpose of this study is to determine the safety and effectiveness of nivolumab and ipilimumab for patients with relapsed or refractory INI1- negative tumors. Patients with multiple types of solid tumors and brain tumors will be included as part of this study. Patients will only be eligible for this study if their tumor has shown a mutation/deletion of a gene that is known to suppress tumor growth called INI1.
What to expect:
Patients will be screened for eligibility by the site study staff
Patients will receive intravenous (IV) treatment with both nivolumab and ipilimumab for 4 cycles and will then receive only nivolumab beginning with Cycle 5
Safety and side effects of study treatment will be monitored at every clinic visit and for 30 days after the last dose of study treatment
Patients will receive a combination of a predetermined dose of nivolumab and ipilimumab every 21 days for a total of 4 cycles.
Starting with Cycle 5, patients will receive a predetermined dose of nivolumab only at day 1 and day 15 every 28 days.
Patient’s must be 6 monts-30 years of age at the time of study enrollment
Histologically confirmed tumor at original diagnosis or relapse
Must have tumor assessment showing the loss of INI1
Relapsed/refractory disease with no standard treatment options
Measurable disease on RANO criteria
All prior treatment side effects are fully resolved, and appropriate treatment washout periods are complete at the time of enrollment
Patients must have adequate organ function that will be confirmed through a routine blood draw
Patients must have adequate pulmonary function
Females of childbearing age must have a negative pregnancy test.
Females and males of childbearing age must agree to use appropriate contraception
Receiving other investigational medication
Use of systemic steroid medications without the approval of the study PI (Topical, inhaled, or ophthalmic steroids are acceptable)
Known history of HIV, hepatitis B or C
Uncontrolled other illness
History of pneumonitis requiring steroids
Active autoimmune disease that has required treatment in the past 12 months or sever autoimmune disease the requires steroids or immunosuppressive medications
Prior organ transplant
Pregnant or breastfeeding
Prior therapy with anti-PD-1, anti-PD-L1, anti-PDl2 or anti-CTLA4 agent
Live vaccine within 30 days of study treatment