Tumor Treatment with Nivolumab with and without Ipilimumab – Phase I/II

Nivolumab in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab

Protocol Description

This multicenter trial by the Children’s Oncology Group seeks to determine the best dose of nivolumab when given with or without ipilimumab, to see how well it works in treating younger patients with solid tumors or sarcomas that have come back or have not responded to standard therapy. Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, study Parts A, B7, and C of this study are open to patients of both genders, ages 13 months to 18 years, with recurrent or refractory solid tumors or metastatic, relapsed, or refractory melanoma; and study Parts B1-B6 are designed for patients 13 months to 30 years of age with relapsed or refractory neuroblastoma, osterosarcoma, rhabdomyosarcoma, Ewing sarcoma, peripheral primitive neuroectodermal tumor, or lymphoma.
Males and Females: Ages 13 months to 30 years

Requirements

Patients enrolled in the study will receive the study drugs by intravenous infusion at intervals specified by the protocol, which varies based on type of tumor.
Visits: Variable, determined by study part in which patient is enrolled
Duration: Patients will be followed for up to 5 years after completing protocol therapy.

Status: Enrollment is limited. Please call to check status.

Source(s) of Support

Children’s Oncology Group (ADVL1412)
National Cancer Institute
Bristol-Myers Squibb

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864