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ONITT: Study of Onivyde with Talazoparib or Temozolomide in Children and Young Adults with Recurrent/Refractory Solid Tumors and Ewing Sarcoma

About this study

This is a research study of a drug called onivyde (liposomal irinotecan) in combination with the drugs talazoparib or temozolomide. All three drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers. The treatment in this study is considered experimental because it has not been proven to work in children and young adults with solid tumors or Ewing sarcoma. We are studying this combination because it seems to work against cancer in the laboratory and animals. This combination has not been tested in children.

If you are accepted to this study, you or your child will receive one of two treatments:

  1. Onivyde + Talazoparib (Arm A), or
  2. Onivyde + Temozolomide (Arm B)

Because there is not much information about this treatment’s effect on cancers in humans, we do not know if you will benefit from taking part in this study. However, what we learn from this study may help future patients with cancer.

Eligibility overview

  • At least 12 months old and 30 years or younger
  • Diagnosed with recurrent or refractory solid tumor (Phase 1)
  • Diagnosed with recurrent or refractory Ewing sarcoma (Phase 2)

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

A Randomized Phase 1/2 Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Study goal:

The main goal of this study is to test new experimental drugs in hopes of finding a treatment that may work against tumors that have come back or that have not responded to standard therapy in children, adolescents and young adults.


12 months to 30 years old

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


Learn more