Status and phase
Conditions
Treatments
About
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
Full description
Cohort C(All Countries) :
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease
BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy.
Cohort P(Japan and the United States Only):
To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.
BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Cohort C Inclusion Criteria
In order to be eligible for participation in this trial, the patient must:
Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent.
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG unresponsive CIS. Patients with BCG unresponsive CIS are those unlikely to benefit from, and who will not be receiving, further intravesical BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols (e.g., BCG weekly × 6 then weekly × 3 weeks administered at Months 3, 6, 12, 18, 24, and 36). Specifically, the definition of BCG unresponsive CIS will also require the following:
Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment (e.g., prior to Day 1 treatment).
Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
Demonstrate adequate organ function
Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial
Cohort P Inclusion Criteria
Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent
Have ECOG performance status of 0 to 2.
Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients with BCG-unresponsive HG Ta/T1 papillary disease are those unlikely to benefit from and who will not be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive HG Ta/T1 papillary disease without CIS will also require the following:
Have all Ta and/or T1 disease resected, prior to study treatment (e.g., prior to Day 1 treatment).
Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy based on Investigator assessment.
Demonstrate adequate organ function,
Patients must be willing to comply with study-mandated cystoscopies, urine cytology, imaging, biopsies, and other procedures for the duration of the trial
Cohort C and Cohort P Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
190 participants in 2 patient groups
Loading...
Central trial contact
JoAnn Horn
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal