Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive t… (NCT07283835) | Clinical Trial Compass
RecruitingPhase 2
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
China16 participantsStarted 2025-12-04
Plain-language summary
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be ≥18 years of age on day of signing informed consent.
✓. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
✓. Demonstrate adequate organ function.
✓. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
✓. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
Exclusion criteria
✕. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
✕. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
✕. Has received systemic anti-cancer therapy, including investigational agents.
✕. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
What they're measuring
1
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
✕. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.