SunRISe-2

Description

A phase 3, randomized, multicenter clinical trial evaluating the efficacy of TAR-200 in combination with cetrelimab compared with standard treatment with concurrent chemoradiotherapy in patients with muscle-invasive bladder cancer (MIBC) who are not undergoing radical cystectomy.

Target

This trial aims to compare two treatment strategies for patients with invasive bladder cancer who wish to avoid complete removal of the bladder. On the one hand, an innovative combination that pairs a local chemotherapy delivery system (TAR-200) with immunotherapy (cetrelimab); on the other, the standard treatment based on concurrent chemotherapy and radiation therapy. The goal is to determine whether the new combination can control the tumor while preserving the bladder and improving progression-free survival.

To whom it is addressed

This study is intended for patients who:

• They have muscle-invasive bladder cancer (MIBC).
• They are not undergoing radical cystectomy (either by choice or because they are not candidates for the procedure).
• They may receive conservative treatment for their bladder.
• They meet the clinical criteria for receiving chemoradiotherapy or immunotherapy.

Treatment

The trial compares two treatment groups:

• TAR-200 + Cetrelimab (experimental group).
• Concurrent chemoradiotherapy (standard treatment).

Patients are randomly assigned to one of these two groups.

What are these treatments?

TAR-200: a device that is inserted into the bladder and continuously releases a chemotherapy drug (gemcitabine) directly into the tumor tissue, allowing for localized action.

Cetrelimab: an intravenously administered immunotherapy (monoclonal antibody) that stimulates the immune system to recognize and attack cancer cells.

Concurrent chemoradiotherapy: a combination of radiation therapy and chemotherapy administered at the same time, which work together to destroy tumor cells.

Study phases

Initial evaluation (screening):
Comprehensive medical tests, imaging studies, and clinical evaluation to confirm that the patient is eligible to participate.

Treatment:

• The TAR-200 is placed in the bladder and replaced periodically.
• Cetrelimab is administered intravenously in cycles.
• In the standard group, patients receive radiation therapy and chemotherapy at the same time.

Follow-up:
Regular checkups including imaging tests, cystoscopies, and clinical examinations to assess response and detect possible relapses.

Duration

Active treatment and follow-up may continue for several years, depending on the patient's progress and response to treatment.

What is evaluated

• Bladder-intact event-free survival (BI-EFS).
• Overall survival.
• Local tumor control.
• Safety and side effects of treatments.
• Patients' quality of life.

Possible risks and side effects

TAR-200 may cause:

• Bladder irritation.
• Urinary problems or infections.

Cetrelimab may cause:

• Fatigue.
• Immune reactions (organ inflammation, rashes, etc.).

Chemoradiotherapy can cause:

• Urinary and intestinal irritation.
• Fatigue.
• Side effects of chemotherapy.

The medical team closely monitors the patient to adjust the treatment based on the patient's tolerance.