Study of CG0070 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
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
Objectives
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
- 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
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