CG Oncology | CRETO-EAP | NCT06443944

About

Bladder cancer is one of the most common cancers in the US, and non-muscle invasive bladder cancer (NMIBC) affects the bladder lining without invading deeper muscle layers. BCG (Bacillus Calmette-Guérin) immunotherapy is the standard treatment for high-risk NMIBC, but some patients’ cancer does not respond or recurs after BCG. These patients have very limited options—approved alternatives are few, and radical bladder removal is often the next step. Better therapies are urgently needed to help patients preserve their bladder and quality of life.

Purpose

This expanded access program provides cretostimogene grenadenorepvec—an investigational oncolytic immunotherapy—to patients with BCG-unresponsive NMIBC who may not qualify for standard clinical trials. The drug is instilled into the bladder weekly for an induction course, followed by quarterly and then biannual maintenance cycles over two years. The primary goal is to provide access to a promising investigational therapy for patients with serious, limited-option disease, while collecting real-world safety and effectiveness data.

Eligibility

• Adults (age ≥18) with BCG-unresponsive NMIBC including carcinoma in situ (CIS), with or without high-grade Ta/T1 disease
• Previously received adequate BCG therapy as defined by the FDA
• No current muscle-invasive or metastatic bladder cancer

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.