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New treatment option for Non Muscle Invasive Bladder Cancer
Official title Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
ClinicalTrials.gov ID: NCT07283835
What this study is testing
What is Cretostimogene Grenadenorepvec?
Cretostimogene Grenadenorepvec is an investigational medicine, being studied as a potential treatment for non muscle invasive bladder cancer.
Also referred to as CG0070.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible for participation in this trial, the patient must:
- Be ≥18 years of age on day of signing informed consent. \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder...
- 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.
You likely can't join if
- 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...
- 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...
- Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral...
- Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
See the full eligibility criteria
- In order to be eligible for participation in this trial, the patient must:
- Be ≥18 years of age on day of signing informed consent. \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without...
- 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...
- Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
- 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.
- 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...
- Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Wuhan, Hubei, China; Changsha, Hunan, China; Nanjing, Jiangsu, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.