Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (BOND-003)
Non Muscular Invasive Bladder Cancer
About this trial
This is an interventional treatment trial for Non Muscular Invasive Bladder Cancer focused on measuring high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin unresponsive
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
Sites / Locations
- Urology Centers of Alabama
- BCG Oncology
- Mayo Clinic Cancer CenterRecruiting
- Arizona Institute of UrologyRecruiting
- University of California - IrvineRecruiting
- American Institute of Research
- Skyline Urology - Sherman Oaks
- Skyline Urology - Torrance
- University of ColoradoRecruiting
- MedStar HospitalRecruiting
- Mayo Clinic - JacksonvilleRecruiting
- Moffit Cancer CenterRecruiting
- Emory UniversityRecruiting
- University of KansasRecruiting
- Chesapeake UrologyRecruiting
- Mayo RochesterRecruiting
- Mercy Medical CenterRecruiting
- New Jersey UrologyRecruiting
- Our Lady of LourdesRecruiting
- Montefiore Medical Center
- StonyBrook Cancer CenterRecruiting
- Duke UniversityRecruiting
- Wake Forest UniversityRecruiting
- University of ToledoRecruiting
- University of Pennsylvania, Perelman School of MedicineRecruiting
- Prisma HealthRecruiting
- Carolina Urologic Research CenterRecruiting
- Vanderbilt University Medical CenterRecruiting
- Baylor Scott and White
- Urology San Antonio, PA
- Spokane Urology
- Barwon Health, University Hospital Geelong
- Royal Melbourne Hospital
- Wollongong Private Hospital
- National Cancer Center Hospital East
- Nagoya University Hospital
- Hirosaki University Hospital
- Chugoku Rosai Hospital
- Shinshu University Hospital
- University of Tsukuba Hospital
- Nara Medical University Hospital
- The Jikei University Kashiwa Hospital
- St. Marianna University Hospital
- National Hospital Organization Kyoto Medical Center
- Kagawa Rosai Hospital
- Keio University Hospital
- Okayama University Hospital
- Osaka City University Hospital
- Osaka Medical and Pharmaceutical University Hospital
- Kitsato University Hospital
- Saitama City Hospital
- Sapporo Medical University Hospital
- Shizuoka General Hospital
- Keio University Hospital
- Ehime University Hospital
- Toyoma University Hospital
- Wakayama Medical University Hospital
- National Hospital Organization Yokohama Medical Center
- Pusan National University Hospital
- National Cancer Center
- Pusan National University Yangsan Hospital
- Chonnam National University Hwasun Hospital
- Seoul National University Hospital
- Korea University Anam Hospital
- Severance Hospital
- The Catholic University of Korea
- Keelung Chang Gung Memorial Hospital
- Keelung Chang Gung Memorial Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Experimental
Single Arm
Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease. CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response) then the patient will receive 3 weekly treatments. Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.