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Brief Title: SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
Official Title: SARC038: A Phase 2 Study of Regorafenib in Combination With Nivolumab in Patients With Refractory or Recurrent Osteosarcoma
Study ID: NCT04803877
Brief Summary: A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.
Detailed Description: This is a single arm, Simon two-stage historically controlled study to compare the 4 month progression-free survival rate of patients with relapsed/refractory osteosarcoma treated with regorafenib in combination with nivolumab to those who received regorafenib alone (historical control).
Minimum Age: 5 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Los Angeles, Los Angeles, California, United States
University of Miami, Miami, Florida, United States
Johns Hopkins, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Cincinnati Children's, Cincinnati, Ohio, United States
Oregon Health and Sciences University, Portland, Oregon, United States
UT Southwestern Medical Center, Dallas, Texas, United States