Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
- 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.
- Short title
- Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-30
- First posted
- 2024-08-23
- Registry last updated
- 2026-04-08
- Primary completion date
- 2027-03-31
- Start date
- 2024-09-16
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- CG Oncology, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06567743
- ClinicalTrials.gov ID
- NCT06567743
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
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
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.
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.
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.
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.
Cohort CX (Arms 1 and 2): Safety
Timeframe: 48 months
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
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.
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
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
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
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.
- 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
- 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.