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

Study of 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 multi-center 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. This study is an initiative of COG’s Pediatric Early Phase Clinical Trial Network of which UPMC Children’s Hospital of Pittsburgh is a part.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders, ages 12 months to 30 years, with recurrent or refractory, neuroblastoma, osterosarcoma, rhabdomyosarcoma, Ewing sarcoma, peripheral primitive neuroectodermal tumor or lymphoma. It is also open to patients 12 months through 17 years with melanoma.
Males and Females: Ages 12 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. At specified intervals, participants will also receive physical examinations, including blood sampling.
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: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1412)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski MD, MS
412-692-5055