Trial Purpose

This phase I/II trial studies the side effects and best dose of pepinemab (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after progression on prior treatment, or did not respond to prior treatment. Immunotherapy with monoclonal antibodies, such as pepinemab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

About the Trial

This is a single-arm, open label study. Patients receive pepinemab in the absence of disease progression or unacceptable toxicity. Primary objectives include safety and antitumor activity with respect to disease control rate at 4 months in pediatric patients with recurrent or refractory patients.

Trial Details

Phase

Phase 1/2

Dates

Actual Study Start Date
January 12, 2018

Estimated Primary Completion Date
December 31, 2020

Estimated Study Completion Date
December 31, 2021

Sponsor

Children’s Oncology Group

Collaborators

National Cancer Institute (NCI)
Vaccinex

Products

pepinemab

Age(s)

1 to 30 years old

Condition(s)

Recurrent or Refractory Malignant Solid Neoplasm, Recurrent or Refractory Osteosarcoma

Gender(s)

All