Trial studying safety and effects for High-Risk Non-Muscle-Invasive Bladder Cancer
Official title Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
ClinicalTrials.gov ID: NCT06567743
What this study is testing
What is Cretostimogene Grenadenorepvec?
Cretostimogene Grenadenorepvec is an investigational medicine, being studied as a potential treatment for high-risk 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
- The study is looking to find out if the drug is safe and works for this type of bladder cancer.
- Who it's for
- Adults who have high‑risk non‑muscle‑invasive bladder cancer.
- What's involved
- Participants will receive the investigational therapy Cretostogene Grenadenorepvec and attend study visits for monitoring and tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Cohort A Key
- 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...
- 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
- 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...
You likely can't join if
- 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...
- Significant immunodeficiency.
- Pregnant or breastfeeding.
- Cohort CX Only: serial intravesical gemcitabine within 24 months
See the full eligibility criteria
- Cohort A Key
- 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
- 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 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...
- 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
- 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...
- Significant immunodeficiency.
- Pregnant or breastfeeding.
- Cohort CX Only: serial intravesical gemcitabine within 24 months
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Irvine, California, United States
- Los Alamitos, California, United States
- Murrieta, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Torrance, California, United States
- Lakewood, Colorado, United States
- Lone Tree, Colorado, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Oxford, Florida, United States
- Atlanta, Georgia, United States
- Chicago Ridge, Illinois, United States
- Glenview, Illinois, United States
+ 50 more site(s).
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, but 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?
This study is enrolling now at Gilbert, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Irvine, California, United States; Los Alamitos, California, United States and 64 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.