Regorafenib + Nivolumab for Osteosarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, you cannot participate if you are using strong CYP3A4 inhibitors or inducers, or if you require oral anticoagulant therapy with oral vitamin K antagonists like warfarin.
Is the combination of Regorafenib and Nivolumab safe for humans?
Regorafenib has been studied for safety in various cancers, including colorectal, liver, and bone cancers, and is FDA-approved for some of these conditions. It has shown survival benefits and improved progression-free survival in these studies, indicating it is generally safe for human use. Nivolumab, often used in combination with other treatments, has also been evaluated for safety in different cancer types.12345
How is the drug combination of Regorafenib and Nivolumab unique for treating osteosarcoma?
The combination of Regorafenib and Nivolumab is unique for treating osteosarcoma because Regorafenib is an oral drug that targets multiple pathways involved in tumor growth, while Nivolumab is an immunotherapy that helps the immune system attack cancer cells. This combination aims to enhance treatment effectiveness by using both targeted therapy and immunotherapy approaches.15678
What data supports the effectiveness of the drug combination Regorafenib and Nivolumab for treating osteosarcoma?
Research suggests that immune-based treatments like Nivolumab, which targets the PD-1 pathway, may improve outcomes in osteosarcoma by preventing immune escape, a process that allows cancer to grow unchecked. Additionally, studies in other cancers have shown that blocking PD-1/PD-L1 interactions can enhance the immune system's ability to fight tumors.910111213
Are You a Good Fit for This Trial?
This trial is for patients aged 5 and older with high-grade osteosarcoma that's come back or hasn't responded to treatment. They need measurable disease on scans, good heart and lung function, no recent major surgeries or uncontrolled diseases, and must not be pregnant. Participants should have recovered from prior treatments and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive regorafenib in combination with nivolumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Regorafenib
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarcoma Alliance for Research through Collaboration
Lead Sponsor