This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug or drug combination to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied. The names of the study drugs involved in this study are: * Nivolumab (OPDIVO) * Ipilimumab (YERYOY) This trial is studying whether nivolumab and ipilimumab work to treat INI1-negative cancers. The U.S. Food and Drug Administration (FDA) has not approved combination nivolumab and ipilimumab for the specific diseases in this study but it has been approved for other diseases. Nivolumab and ipilimumab have been tested in children to find out a safe dose of this combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Combination Therapy: Nivolumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles. Monotherapy: Starting with cycle 5 nivolumab at predetermined dosage on day 1 and day 15 of a 28-day cycle
Combination Therapy: Ipilimumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
Children's Healthcare of Atlanta-Scottish Rite
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Objective Overall Response Rate (Stratum 1)
Based on Response Evaluation in Solid Tumors (RECIST) version 1.1
Time frame: 12 months
Objective Overall Response Rate (Stratum 2)
Based on Response Assessment in Neuro-Oncology (RANO) Criteria
Time frame: 12 months
Progression-free survival (PFS)
Time from study enrollment until the first occurrence of disease progression, relapse or death due to disease
Time frame: 3 years
Overall survival (OS)
Time from study enrollment until death from any cause
Time frame: 3 years
Disease control rate at 12 months
The proportion of patients who are progression-free at 12 months
Time frame: 12 Months
Occurrence of toxicities (Grade 3-5 per CTCAE)
Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Time frame: 13 months
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