RECRUITING

Brief Title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

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Conditions

High-Risk Non-Muscle-Invasive Bladder CancerBladder Cancer

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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 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.

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)

Quick Facts

Study Start:2024-09-16
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06567743

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. * Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.
  2. * Participants with BCG-naïve NMIBC should have either:
  3. * No prior treatment with BCG OR
  4. * No treatment with BCG within the past 24 months prior to current pathological diagnosis OR
  5. * A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.
  6. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
  7. * Acceptable baseline organ function.
  1. * Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
  2. * High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.
  3. * Significant immunodeficiency.
  4. * Pregnant or breastfeeding.

Contacts and Locations

Study Contact

Rebecca Tregunna, MD
CONTACT
+1.949.419.6105
Rebecca.Tregunna@cgoncology.com
Andy Darilek
CONTACT
+1.406.628.5708
andy.darilek@CGoncology.com

Principal Investigator

Pat Keegan
STUDY_DIRECTOR
CG Oncology

Study Locations (Sites)

Southern Urology (Urology America)
Lafayette, Louisiana, 70508
United States
The Conrad Pearson Clinic (Urology America)
Germantown, Tennessee, 38138
United States
Urology Austin, PLLC (Urology America)
Austin, Texas, 78745
United States

Collaborators and Investigators

Sponsor: CG Oncology, Inc.

  • Pat Keegan, 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 Date2024-09-16
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • Bladder Cancer

Additional Relevant MeSH Terms

  • High-Risk Non-Muscle-Invasive Bladder Cancer