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). Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether nivolumab works better alone or with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.

Conditions: Childhood Solid Neoplasm; Metastatic Melanoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Hodgkin Lymphoma; Recurrent Melanoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Rhabdomyosarcoma; Refractory Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma Interventions: Biological: Ipilimumab; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Other: Pharmacological Study

Principal Investigator:
Josephine HaDuong, MD

Research Coordinator:
Tina Templeman
(714) 509-8646

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  • Clinical Trial Info
  • IRB Number: 150109
  • Sponsor: COG
  • Protocol Number: ADVL1412
  • NCT Number: NCT02304458
  • Research Type: Adolescents and Young Adults, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I/II
  • Status: Active - Open to Enrollment

Key Inclusion Criteria:

  • Parts A & C: patients must be >= 12 months and < 18 years of age at the time of study enrollment
  • Parts B1-B6, B8, D1-D6: patients must be >= 12 months and =< 30 years of age at the time of study enrollment
  • Part B7: patients must be >= 12 months and < 18 years of age at the time of study enrollment
  • Patients must have had histologic verification of malignancy at original diagnosis or relapseStandard COG Phase 1 organ function requirementsNo evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air

Key Exclusion Criteria:

  • Patients with CNS tumors or known CNS metastases will be excluded from this trial; patients with a history of CNS metastases that have been previously treated may enroll if sequential imaging shows not evidence for active disease; patients with extra axial disease (e.g. skull [bone] metastasis that do not invade the dura) may enroll if there is no evidence for CNS edema associated with the lesionPatients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody [ANA], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorderPatients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibilityPatients with a history of congestive heart failure (CHF) or are at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs must have adequate cardiac function as clinically indicated:Corrected QT interval (QTC) =< 480 msecShortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by gated radionuclide studyPatients who have received prior solid organ transplantation are not eligiblePatients who have received prior anti-PD1 directed therapy (monoclonal antibody [mAb] or small molecule) are not eligible