Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC), Unresponsive to Bacillus-Calmette-Guerin (BCG)

JRCT ID: jRCT2043210017

Registered date:11/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non Muscular Invasive Bladder Cancer
• Date of first enrollment: 01/05/2021
• Target sample size: 110
• Countries of recruitment: US,Japan,Australia,Japan,Taiwan,Japan,South Korea,Japan
• Study type: Interventional
• Intervention(s): intravesically (IVE) administration

Outcome(s)

• Primary Outcome: Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)

Secondary Outcome

-Median Duration of response (DOR)
-Median progression free survival
-Incidence of adverse events when CG0070 administered alone
-Comparison of complete response in patients with persistent disease versus relapsed disease at baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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):
1.At least five of six to eight doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR
2.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

Exclude 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

Related Information

• Primary Sponsor: Shimizu Yoshitaka
• Secondary ID(s): NCT04452591