Bladder Cancer Clinical Trial
Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Summary
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
Full Description
An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that will enroll up to 110 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.
Eligibility Criteria
Key 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
Key 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
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There are 38 Locations for this study
Homewood Alabama, 35209, United States
Phoenix Arizona, 85032, United States
Phoenix Arizona, 85054, United States More Info
Principal Investigator
Tucson Arizona, 85704, United States More Info
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Principal Investigator
Irvine California, 92868, United States More Info
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Principal Investigator
Los Angeles California, 90017, United States
Sherman Oaks California, 91411, United States
Torrance California, 90505, United States
Washington District of Columbia, 20010, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Kansas City Kansas, 66160, United States More Info
Principal Investigator
Edison New Jersey, 08837, United States More Info
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Principal Investigator
Bronx New York, 10461, United States
Stony Brook New York, 11794, United States More Info
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Durham North Carolina, 27710, United States More Info
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Principal Investigator
Winston-Salem North Carolina, 27109, United States More Info
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Toledo Ohio, 43614, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Greenville South Carolina, 29615, United States More Info
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Myrtle Beach South Carolina, 29572, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Principal Investigator
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Spokane Washington, 99202, United States
Geelong , , Australia
Melbourne , , Australia
Wollongong , , Australia
Chiba , , Japan
Fujita , , Japan
Hashimoto , , Japan
Hiroshima , , Japan
Ishizuka , , Japan
Kandori , , Japan
Kashihara , , Japan
Kashiwa , , Japan
Kikuchi , , Japan
Kyoto , , Japan
Marugame , , Japan
Matsumoto , , Japan
Okayama , , Japan
Osaka , , Japan
Osaka , , Japan
Sagamihara , , Japan
Saitama , , Japan
Sapporo , , Japan
Shizuoka , , Japan
Tokyo , , Japan
Toon , , Japan
Toyoma , , Japan
Wakayama , , Japan
Yokohama , , Japan
Busan , 49241, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeongsang , 50612, Korea, Republic of
Jeongnam , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Keelung City , , Taiwan
Keelung , 204, Taiwan
Taichung , 40447, Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
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