> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-2-study-to-evaluate-safety-and-efficacy-of-be30dbee-a9ca-47af-ae7d-781003d1deb9 > Record changed: 2026-10-13 # Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC NCT06567743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Participants 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Lead sponsor CG Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Start date 2024-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) Number of sites 65 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Title and summary **Summary** This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Short title** Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Official title** A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Dates **Completion date** 2027-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **First posted** 2024-08-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Registry last updated** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Primary completion date** 2027-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Start date** 2024-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Size and sites **Participants** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Planned participants** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Number of sites** 65 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Lead sponsor** CG Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Identifiers **Registry ID** NCT06567743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **ClinicalTrials.gov ID** NCT06567743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Outcomes ### Primary outcomes 1. Cohort A (Arm 1 and 2): Complete response rate Timeframe: At 11 and 24 weeks Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline 2. Cohort A (Arm 3): High- Grade Event-Free Survival Timeframe: 48 months Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline. 3. Cohort B (Arm 1): Complete response rate Timeframe: At 11 and 24 weeks Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline. 4. Cohort B (Arm 2): High-Grade Event-Free Survival Timeframe: 48 months Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline. 5. Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival Timeframe: 48 months Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC. 6. Cohort CX (Arms 1 and 2): Safety Timeframe: 48 months Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine. ### Secondary outcomes 1. Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods Timeframe: At 11 and 24 weeks Evaluate cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment. 2. Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months Timeframe: At 12 months Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months 3. Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response Timeframe: 48 months Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline 4. Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months Timeframe: At 12 months Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months 5. Cohort CX (Arm 1 and 2) Complete response rate Timeframe: At 11 and 24 weeks Determine the complete response rate at any time following treatment with cretostimogene and gemcitabine in participants with BCG-exposed or BCG-unresponsive CIS with or without concomitant high-grade Ta or T1 disease at baseline. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Cohort A Key Inclusion Criteria: - Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Cohort B Key Inclusion Criteria: - Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Cohort CX Inclusion Criteria - Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Key Exclusion Criteria (Both Cohorts): - Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer. - High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract. - Significant immunodeficiency. - Pregnant or breastfeeding. - Cohort CX Only: serial intravesical gemcitabine within 24 months Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Sites - Mayo Clinic ArizonaPhoenix, United StatesRecruiting - Arizona Urology SpecialtyTucson, United StatesWithdrawn - University of Arkansas for Medical SciencesLittle Rock, United StatesRecruiting - Arkansas UrologyLittle Rock, United StatesRecruiting - Michael G Oefelein, MD Clinical TrialsBakersfield, United StatesRecruiting - Genesis Research (Greater Los Angeles)Los Alamitos, United StatesRecruiting - Advanced UrologyLos Angeles, United StatesWithdrawn - Urology Center of Southern CaliforniaMurrieta, United StatesRecruiting - University of California, IrvineOrange, United StatesRecruiting - Om researchSan Diego, United StatesRecruiting - University of Southern CaliforniaSan Diego, United StatesRecruiting - Genesis Research (Greater Los Angeles)Torrance, United StatesRecruiting - Colorado UrologyLakewood, United StatesRecruiting - Urology Associates, Lone TreeLone Tree, United StatesRecruiting - University of FloridaGainesville, United StatesRecruiting - Mayo Clinic FloridaJacksonville, United StatesRecruiting - Advanced Urology Institute (Solaris)Largo, United StatesRecruiting - Advanced Urology InstituteOxford, United StatesRecruiting - Advanced Urology Institute - Tallahassee (Solaris)Tallahassee, United StatesWithdrawn - Emory UniversityAtlanta, United StatesRecruiting - Associated Urological SpecialistsChicago Ridge, United StatesRecruiting - UropartnersGlenview, United StatesRecruiting - Urology of Indiana - CarmelCarmel, United StatesRecruiting - Urology of Indiana, LLC (US Urology Partners)Greenwood, United StatesRecruiting - First Urology, PSCJeffersonville, United StatesRecruiting And 40 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06567743) ## Related records ### Drugs (1) - [Cretostimogene grenadenorepvec](https://trialight.com/data/asset/cretostimogene-grenadenorepvec-26de589d-9a3f-4438-b425-9679f35f4390.md) ### Lead sponsors (1) - [CG Oncology, Inc.](https://trialight.com/data/company/cg-oncology-inc-690469c2-d31b-4b39-ba64-d21e7f05d222.md) ### Conditions (1) - [Urinary bladder neoplasm](https://trialight.com/data/condition/urinary-bladder-neoplasm-269fb796-5527-5895-bad6-63dc153c3401.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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