ACTIVE_NOT_RECRUITING

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

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Conditions

Non Muscle Invasive Bladder CancerHigh-grade Ta/ T1 Papillary Disease Bladder Cancerhigh-grade Ta papillary diseasehigh-grade T1 papillary diseasecarcinoma in situBacillus-Calmette-Guerin unresponsive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC

Official Title

A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

Quick Facts

Study Start:2020-10-27
Study Completion:2029-12-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04452591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
  2. * Any HGUC as T1, HG Ta, or CIS in the upper genitourinary tract or prostatic urethra (including CIS of the urethra) within 24 months prior to enrollment OR any history of T2 or higher stage urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters).
  3. * Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1.
  4. * 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.
  5. * 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, uncontrolled hypertension, or uncontrolled congestive heart failure.
  6. * Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of cretostimogene.
  7. * IVE therapy within 8 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted 14 or more days prior to beginning study treatment

Contacts and Locations

Principal Investigator

CG Oncology
STUDY_DIRECTOR
CG Oncology

Study Locations (Sites)

Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
United States
Arizona Institute of Urology
Tucson, Arizona, 85704
United States
Arkansas Urology
Little Rock, Arkansas, 72211
United States
University of California - Irvine
Irvine, California, 92868
United States
University of Colorado
Aurora, Colorado, 80045
United States
Colorado Clinical Research
Lakewood, Colorado, 80228
United States
Urology Associates
Lone Tree, Colorado, 80124
United States
MedStar Hospital
Washington, District of Columbia, 20010
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
United States
Moffit Cancer Center
Tampa, Florida, 33612
United States
Emory University
Atlanta, Georgia, 30322
United States
Urology of Indiana
Greenwood, Indiana, 46143
United States
University of Kansas
Kansas City, Kansas, 66160
United States
Wichita Urology
Wichita, Kansas, 67226
United States
Southern Urology
Lafayette, Louisiana, 70508
United States
Chesapeake Urology
Severna Park, Maryland, 21076
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Mayo Rochester
Rochester, Minnesota, 55905
United States
Mercy Medical Center
Saint Louis, Missouri, 63109
United States
Washington University
Saint Louis, Missouri, 63130
United States
Specialty Clinical Research of St. Louis
Saint Louis, Missouri, 63141
United States
Duke University
Durham, North Carolina, 27710
United States
University of Toledo
Toledo, Ohio, 43614
United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17601
United States
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Conrad Pearson Clinic
Germantown, Tennessee, 38138
United States
Urology Associates- Nashville
Nashville, Tennessee, 37209
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Houston Metro Urology
Houston, Texas, 77027
United States
Urology San Antonio, PA
San Antonio, Texas, 78229
United States
Spokane Urology
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: CG Oncology, Inc.

  • CG Oncology, STUDY_DIRECTOR, CG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-27
Study Completion Date2029-12-24

Study Record Updates

Study Start Date2020-10-27
Study Completion Date2029-12-24

Terms related to this study

Keywords Provided by Researchers

  • high-grade Ta papillary disease
  • high-grade T1 papillary disease
  • carcinoma in situ
  • Bacillus-Calmette-Guerin unresponsive

Additional Relevant MeSH Terms

  • Non Muscle Invasive Bladder Cancer
  • High-grade Ta/ T1 Papillary Disease Bladder Cancer