A Phase 3 Study of CG0070 In Patients with Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease
To determine the Complete Response rate at any time of CG0070 in patients with BCG-unresponsive carcinoma in situ (CIS) with or without concomitant high-grade Ta (TaHG) or T1 papillary disease
Assess duration of response
Assess progression free survival
Assess Complete Response rate at 12 months
Determine cystectomy free survival
Determine the frequency of progression to higher grade or higher stage disease (e.g., development of muscle invasive [T2] disease and metastatic disease)
Assess the rate of delayed response beyond 3 months following treatment with CG0070
Evaluate differential response in patients with history of persistent (e.g., induction failure) and relapsed disease following past BCG treatment
Evaluate the safety of CG0070
Assess overall survival
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Have pathologically confirmed World Health Organization (WHO) grading system employed for tumor grading) high-risk NMIBC unresponsive to prior BCG therapy defined as:
Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy
Received prior adequate BCG therapy as defined as at least one of the following ("5+2" minimum exposure):
At least five of six doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR
At least five of six doses of an initial induction course (adequate induction) plus at least two of six doses of a second induction course.
Ineligible for radical cystectomy or refusal of radical cystectomy
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