A Phase 2-3 Study Assessing the Addition of Cabozantinib to Chemotherapy in People With Newly Diagnosed Osteosarcoma

Full Title

A Feasibility and Randomized Phase 2/3 Study of the VEGFR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma (AOST2032) (CIRB)

Purpose

Researchers want to see if adding cabozantinib to standard chemotherapy works better than chemotherapy alone for osteosarcoma. The people in this study include children, adolescents, and young adults with osteosarcoma that has not yet been treated.

Cabozantinib blocks protein signals involved in the growth of blood vessels that tumors need to grow and spread. It is taken orally (by mouth). The standard chemotherapy drugs include methotrexate, doxorubicin, and cisplatin. They are given intravenously (by vein).

If you take part in this study, you or your child will be randomly assigned to get standard chemotherapy alone or with cabozantinib.

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have been newly diagnosed with osteosarcoma.
  • Have not received treatment for osteosarcoma.
  • Be under age 40.

Contact

For more information and to see if you or your child can join this study, please call 833-MSK-KIDS.

Protocol

25-334

Phase

Phase II/III (phases 2 and 3 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05691478