Phase 2 Study of Regorafenib and Nivolumab for Osteosarcoma

Inclusion Criteria

• Be 5 years or older, with efforts to include 50% of participants who are 21 or younger.
• Have a confirmed diagnosis of high-grade osteosarcoma, not related to Paget's disease or occurring outside the bone.
• The cancer must have returned or not responded after at least one previous treatment.
• Be in good general health, able to perform daily activities, or use a wheelchair if needed.
• Have at least one tumor that can be measured by scans.
• Be able to swallow pills.
• Have adequate organ and bone marrow function, as shown by specific blood tests.
• Have good lung and heart function.
• Have recovered from any previous treatments.
• Agree to use effective birth control during the study and for a period after the last dose of medication.
• Women of childbearing potential must have a negative pregnancy test before starting the study.
• Be willing to provide a tumor sample if over 18 years old.

Exclusion Criteria

• Have another type of cancer that could interfere with the study.
• Have severe or uncontrolled medical conditions that could pose safety risks.
• Have had major surgery or significant injury within 28 days before starting the study.
• Be pregnant or breastfeeding.
• Have allergies to the study drugs or similar medications.
• Be unable to follow the study procedures.
• Have previously received certain types of cancer treatments.
• Have an autoimmune disease or require long-term use of immunosuppressive drugs.
• Have an active infection or uncontrolled high blood pressure.
• Have had a significant blood clot or bleeding event recently.
• Have a non-healing wound or ulcer.
• Have significant digestive issues causing diarrhea.
• Have received a live vaccine recently.
• Be taking certain medications that could interfere with the study drugs.