ivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas

• Conditions: •Childhood Solid Neoplasm•Recurrent Childhood Rhabdomyosarcoma•Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor•Recurrent Neuroblastoma•Recurrent Osteosarcoma•Recurrent Hodgkin Lymphoma•Recurrent Non-Hodgkin Lymphoma; MedDRA version: 17.1Level: PTClassification code 10031296Term: Osteosarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 17.1Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10066595Term: Neuroblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10015564Term: Ewing's sarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10039027Term: Rhabdomyosarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005674-11-Outside-EU/EEA
• Lead Sponsor: ational Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-08
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

•Parts A & C: patients must be >= 12 months and =< 18 years of age at the time of study enrollment
•Part B: patients must be >= 12 months and =< 30 years of age at the time of enrollment
•Patients must have had histologic verification of malignancy at original diagnosis or relapse
?Parts A & C: patients with recurrent or refractory solid tumors, without central nervous system (CNS) tumors or known CNS metastases, are eligible; note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated
?Part B1: patients with relapsed or refractory neuroblastoma
?Part B2: patients with relapsed or refractory osteosarcoma
?Part B3: Patients with relapsed or refractory rhabdomyosarcoma
?Part B4: Patients with relapsed or refractory Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET)
¦If Part B is open while Part C is enrolling, eligible patients will preferentially enroll on Part B
•Parts A & C: patients must have either measurable or evaluable disease
•Part B: patients must have measurable 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
•Karnofsky >= 50% for patients > 16 years of age and Lansky >= 60 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
•Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
•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; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the Study Chair
•At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the Study Chair
•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
•At least 14 days after local palliative external beam radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation
•For patients with solid tumors without known bone marrow involvement:
•No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
•Peripheral absolute neutrophil count (ANC) >= 750/mm^3
•Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
•Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (may receive transfusions provided they ar

Exclusion Criteria

•Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; females of childbearing potential must be willing to adhere to effective contraception during and for 23 weeks after the last dose of nivolumab; males who are sexually active with women of childbearing potential must be willing to adhere to effective contraception during and for 31 weeks after the last dose of nivolumab
•Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
•Patients who are currently receiving another investigational drug are not eligible
•Patients who are currently receiving other anti-cancer agents are not eligible
•Patients with CNS tumors or known CNS metastases will be excluded from this trial
•Patients 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 disorder
•Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
•Patients who have an uncontrolled infection are not eligible
•Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded
•Patients who have received prior solid organ transplantation are not eligible
•Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
•Patients who have received prior anti-PD1 monoclonal antibody (mAb) therapy are not eligible

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified