LAUREL Study

What is the LAUREL study?

The LAUREL study is a clinical research study for adults with non-muscle invasive bladder cancer (NMIBC) who need transurethral resection of bladder tumor (TURBT). The goal of the study is to find out if the study medicine is safe and does not cause too many side effects when delivered directly into the bladder. Researchers also hope to learn how the body processes the study medicine.

Who can join the LAUREL study?

Study participants may be able to join the study if they meet the following requirements:

• 18 years of age or older
• Diagnosed with Ta or T1 NMIBC without carcinoma in situ (CIS)
• Cancer returned after standard-of-care therapy
• Planning to have TURBT without chemotherapy

Other study requirements apply. Ask your doctor if you qualify and if the LAUREL study is a good option for you.

What will happen during the study?

The study is divided into phases and periods.

• For participants who join during Phase 1, participation will last about 118 days.
• For participants who join during Phase 2a, participation will last about 2 years.

These are the study periods:

• Screening (Up to 28 days):
• Have study assessments to find out if you can be in the study.
• TURBT and study medicine (1 day)
• Have your TURBT procedure
• Receive an injection of the study medicine
• Have study assessments
• Follow-up (90 days or 2 years, depending on when you enroll)
• If you enroll during Phase 1 or 2a, you will have some study visits during the 90 days after TURBT for follow-up study assessments.
• If you enroll during Phase 2a, you will also have study visits every 3 months for about 2 years, which is in line with typical standard-of-care follow-up.

The support of Patient Concierge Services (PCS) will be available to help patients with travel needs along with payment services (i.e meal reimbursements) to help reduce financial burden and logistical planning stresses.

Below are the travel and payment services that are offered:

There will be a dedicated team that provides one-on-one support for patients that are needing travel accommodations or payment services.

• Hotel
• Car rental
• Car service (rideshare or private car, if necessary)
• Meal reimbursements
• Caregiver Travel, Accommodations and Reimbursements
• 1 caregiver per patient

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.