The Orion-BC study is researching a study therapy that may be able to help people with bladder cancer. The study is for people whose bladder cancer has not been consistently responsive or has returned after BCG treatment.
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You may be eligible to join the Orion-BC study if you meet the following criteria*:
- 18 years or older
- Diagnosed with non-muscle invasive bladder cancer with no evidence of metastases (has not spread to other organs) demonstrated by abdominal CT scan or MRI.
- Have already received the standard of care treatment (BCG)
Patient has received at least five of six does of an initial induction course plus either at least two of six doses of a second induction course OR at least two of three doses of maintenance therapy - Not able or not willing to have your bladder surgically removed
*Other study criteria apply. Contact a clinic near you to learn more.
Participation in the Orion-BC study lasts a maximum of 4 years. This study is for individuals with persistent high-grade bladder cancer despite adequate BCG treatment as well as individuals whose bladder cancer has returned after achieving a disease-free state after adequate BCG treatment. Study participants can expect the following:
- Informed Consent: Participants will read and sign the Informed Consent Form (ICF) before they receive any study assessments.
- Screening Period: Participants will receive study assessments to confirm if they qualify for the study.
- Induction Phase: Participants will receive the study therapy (intravesical: delivered straight to the bladder through a catheter) once a week for 12 weeks.
- Possible Maintenance Phase: Depending on the results of the investigational therapy during the induction phase, participants may continue to receive the study therapy once a month for up to 1 year.
- Follow-up Period: After participants last dose of study therapy, they will visit the study clinic for final study assessments
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
