A Phase 1/2 Study of Nivolumab in Children Adolescents and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab
James Croop, MD, PhD
Primary Investigator
Brief description of study
The purpose of this study is to determine the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory).
Detailed description of study
This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Solid Tumor,Cancer,Childhood Hodgkin Lymphoma
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Age: 1 years - 30 years
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Gender: All
Inclusion Criteria
Patients must have had histologic verification of malignancy at original diagnosis or relapse
Patients must have either measurable or evaluable disease
Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor
At least 7 days after the last dose of a biologic agent
At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion
Patients must not have received prior exposure to nivolumab
Exclusion Criteria
Pregnant or breast-feeding women
Patients requiring daily systemic corticosteroids
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anti-cancer agents
Patients with CNS tumors or known CNS metastases
Patients with a history of any grade autoimmune disorder
Patients who have an uncontrolled infection
Patients with known human immunodeficiency virus (HIV) or hepatitis B or C
Patients who have received prior solid organ transplantation
Patients who have received prior anti-PD1 monoclonal antibody (mAb) therapy
Additional Information:
