SunRISe-1

Description

Phase 2b study evaluating the efficacy and safety of TAR-200 (with or without cetrelimab) in patients with high-risk, non-muscle invasive bladder cancer who have not responded to BCG treatment and who are unable or unwilling to undergo radical cystectomy (complete removal of the bladder).

Target

This trial seeks new alternatives for treating high-risk bladder cancer when standard BCG treatment no longer works and major surgery is to be avoided. It combines a new way of delivering chemotherapy directly into the bladder (TAR-200) with an immunotherapy (cetrelimab) that activates the body's defenses. The objective is to eliminate the tumor without the need to remove the bladder, maintaining the patient's quality of life.

To whom it is addressed

This study is intended for patients who:

• Have high-risk bladder cancer that has not responded to BCG treatment.
• They are unable or unwilling to undergo radical cystectomy.
• They have carcinoma in situ (CIS), with or without papillary tumors (Ta or T1).

Treatment

The trial evaluates three treatment options and patients are randomly assigned to one of the three groups:

• TAR-200 + Cetrelimab
• TAR-200 alone
• Cetrelimab alone

What are these drugs?

TAR-200: a device that slowly releases a drug (gemcitabine) directly into the bladder. It is inserted through a catheter and remains in place for about three weeks, slowly releasing the drug to attack the cancer cells from inside the bladder. It is then removed by cystoscopy and can be replaced periodically.

Cetrelimab: is a monoclonal antibody (an immunotherapy) that is administered intravenously (through the serum). It works by activating the patient's immune system to recognize and destroy tumor cells.

Study phases

Initial evaluation (screening): analyses, imaging tests (CT or MRI) and cystoscopy are performed to confirm that the patient meets the criteria.

Treatment:

TAR-200 is applied to the bladder every 3 weeks for the first 6 months and then every 3 months for up to 2 years.

Cetrelimab (if applicable) is administered intravenously every 3 weeks for about 18 months.

Follow-up: patients are periodically reviewed with cystoscopies and urine cytology (every 3 months for the first 2 years, then every 6 months). CT or MRI scans are also performed to check the evolution.

Duration of the study

Treatment and follow-up may last up to 5 years, depending on the evolution of each patient.

What is evaluated

• Complete response rate (CR): percentage of patients in whom the cancer disappears completely.
• Duration of response: how long you remain disease-free.
• Overall survival.
• Safety and side effects of treatments.
• Quality of life of patients using validated questionnaires.

Possible risks and side effects

TAR-200 may cause urinary discomfort, infection or bladder irritation.

Cetrelimab, being an immunotherapy, may cause side effects related to the activation of the immune system (fatigue, rash, organ inflammation, etc.). The medical team closely monitors any adverse effects and adapts the treatment if necessary.