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A Phase II Trial of Avelumab, a Fully Human Antibody That Targets Cells Expressing PD-L1, in Patients with Recurrent or Progressive Osteosarcoma
Diseases
Recurrent or Refractory Osteosarcoma
Description
This is a multiple center phase II Trial of a PD-L1 inhibitor, Avelumab, for patients 12 years or greater with recurrent or refractory osteosarcoma. This trial is testing whether osteosarcoma has a response to Avelumab, and whether Avelumab extends the survival of patients with relapsed or refractory disease. The medication is given intravenously once every 2 weeks for up to 24 months for patients in whom the medication is effective.
Avelumab will be evaluated using dosing that has previously been determined in adult studies. The primary objectives of the study is to estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma. The 16-week progression free survival after treatment with avelumab will be studied. Other secondary objectives are to describe the toxicities associated with the administration of avelumab and measure quality of life of patients with recurrent or progressive osteosarcoma undergoing treatment with avelumab.
Eligibility Criteria
Ages Eligible for Study: 12 Years to 49 Years (Child, Adult)
Sexes Eligible for Study: All
Other Inclusion and exclusion criteria as listed on clinicaltrials.gov.
