Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
CG3002S (primary)
NCI-2021-01691
Summary
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
Objectives
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.
Eligibility
- 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:
- Pathologically confirmed recurrent HG Ta/T1 papillary disease without CIS within 6 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies).
- Patients with HG Ta: Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time).
- Patients with HG T1: Patients may be eligible after the initial induction alone (5 of 6 doses of an induction course) as the qualifying BCG treatment.
- Completion (last dose) of qualifying BCG treatment within 12 months of study enrollment.
- Pathological confirmation of BCG-unresponsive HG Ta/T1 papillary disease without CIS within 8 weeks of study enrollment.
- All pathology specimens must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
- No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG
- 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
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