A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Launched by CG ONCOLOGY, INC. · Oct 30, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for patients with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC) that is considered to be of intermediate risk. The trial is looking at whether a specific treatment called cretostimogene grenadenorepvec, given after a procedure to remove tumors from the bladder (called TURBT), can help prevent the cancer from coming back compared to just monitoring the patients after the procedure.
To participate in the trial, patients need to have certain types of intermediate-risk NMIBC confirmed by doctors, and all visible tumors must have been removed in the last 12 weeks. The trial is open to all adults aged 65 to 74 years and is currently recruiting participants. Those who take part can expect regular check-ups and monitoring to see how well the treatment is working. It's important to know that this trial is not for patients with high-risk or low-risk NMIBC or other specific bladder issues.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
- • 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
- • 2. Solitary LG Ta \>3 cm tumor
- • 3. Multifocal LG Ta tumors
- • 4. Primary and solitary HG Ta ≤3 cm tumor
- • 5. LG T1 tumor
- • All visible disease removed by TURBT within 90 days of study randomization
- • Acceptable baseline organ function
- Exclusion Criteria:
- • High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\>3cm tumor(s), CIS)
- • Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
- • Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
- • Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
- • Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)
About Cg Oncology, Inc.
cg oncology, inc. is a pioneering biopharmaceutical company dedicated to advancing innovative therapies for the treatment of cancer. With a robust pipeline of novel immuno-oncology agents, cg oncology is committed to enhancing patient outcomes through cutting-edge research and development. The organization's focus on precision medicine and collaboration with leading research institutions positions it at the forefront of cancer treatment innovation. By leveraging state-of-the-art technologies and a patient-centric approach, cg oncology strives to transform the landscape of cancer care and improve the lives of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Charleston, South Carolina, United States
Boston, Massachusetts, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Rochester, New York, United States
Sacramento, California, United States
Chicago, Illinois, United States
Charleston, West Virginia, United States
Stanford, California, United States
Scottsdale, Arizona, United States
Toledo, Ohio, United States
Miami, Florida, United States
Columbus, Ohio, United States
Seattle, Washington, United States
Nashville, Tennessee, United States
Bronx, New York, United States
Morgantown, West Virginia, United States
Washington, District Of Columbia, United States
Syracuse, New York, United States
Houston, Texas, United States
Philadelphia, Pennsylvania, United States
New York, New York, United States
Seattle, Washington, United States
Myrtle Beach, South Carolina, United States
Saint Louis, Missouri, United States
Shreveport, Louisiana, United States
Houston, Texas, United States
Providence, Rhode Island, United States
Greenwood, Indiana, United States
London, Ontario, Canada
Nashville, Tennessee, United States
Troy, Michigan, United States
Germantown, Tennessee, United States
Los Angeles, California, United States
Stony Brook, New York, United States
Arlington, Texas, United States
Vancouver, British Columbia, Canada
Houston, Texas, United States
Gilbert, Arizona, United States
Daytona Beach, Florida, United States
Southaven, Mississippi, United States
New York, New York, United States
Bala Cynwyd, Pennsylvania, United States
Jacksonville, Florida, United States
Salt Lake City, Utah, United States
Durham, North Carolina, United States
Carmel, Indiana, United States
Hartford, Connecticut, United States
Hershey, Pennsylvania, United States
Wichita, Kansas, United States
Lakeland, Florida, United States
San Antonio, Texas, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
San Antonio, Texas, United States
Orange, California, United States
Homewood, Alabama, United States
Lafayette, Louisiana, United States
North Charleston, South Carolina, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Baltimore, Maryland, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Orange, California, United States
Lone Tree, Colorado, United States
Largo, Florida, United States
Savannah, Georgia, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
New York, New York, United States
Springfield, Oregon, United States
Houston, Texas, United States
Spokane, Washington, United States
Lisle, Illinois, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States
Montréal, Quebec, Canada
Glenview, Illinois, United States
Atlanta, Georgia, United States
Reno, Nevada, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Virginia Beach, Virginia, United States
Aurora, Colorado, United States
West Des Moines, Iowa, United States
Syracuse, New York, United States
Amarillo, Texas, United States
Madison, Wisconsin, United States
Roseville, Michigan, United States
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Patients applied
Trial Officials
Robert Svatek, MD
Principal Investigator
University of Texas Health Science Center San Antonio
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported