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*:
- Male or female
- 18 years or older
- Diagnosed with Carcinoma In Situ of the Bladder (CIS) with no evidence of metastases (has not spread to other organs) demonstrated by abdominal CT scan or MRI within 3 months prior to start of treatment. Have already received the standard of care treatment, BCG.
- o Patient has received at least five of six doses 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
- Are within 12 months of completion of adequate BCG therapy (at the time of enrollment)
- Not able, not willing, or unfit 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 53 months. 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, including a cystoscopy and tumour biopsy, to confirm if they qualify for the study.
- Induction Phase: Participants will receive the study therapy (intravesical instillation: delivered straight to the bladder through a catheter) once a week for 12 weeks. At the end of this phase, participants will undergo another tumour assessment and biopsy so the study doctor can see if your tumour has responded (gotten smaller) after receiving the study therapy.
- Possible Re-induction phase: If the tumour assessment after the induction phase reveals some cancer remains (residual CIS), participants are eligible to continue receiving once weekly intravesical instillations for 12 more weeks.
- Possible Maintenance phase: Depending on the results of the investigational therapy during the induction and/or re-induction phases 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 study tests and assessments. Participants will continue to receive assessments to monitor how they are responding to the study therapy after completing instillations and safety.
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.
