Status and phase
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About
A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Must have relapsed or refractory osteosarcoma following at least one line of systemic therapy for the initial treatment of osteosarcoma.
Patients >18 years must be willing to undergo tumor biopsy at study entry and post-treatment biopsy for biologic correlates. If biopsy is contra-indicated, enrollment must be approved by study PI and archival tissue must be available.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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