Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
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
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
Not Available
Phase III
Adults
Not Available
Not Available
Not Available
National
Vanderbilt University
07-05-2022
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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
Adequate organ function
Exclusion Criteria:
Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
Has known upper tract or prostatic urethra malignancy
Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of Baseline
Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
Prior treatment with adenovirus-based cancer therapy
Clinically significant or active cardiac disease
Active autoimmune disease
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
Adequate organ function
Exclusion Criteria:
Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
Has known upper tract or prostatic urethra malignancy
Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of Baseline
Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
Prior treatment with adenovirus-based cancer therapy
Clinically significant or active cardiac disease
Active autoimmune disease
