To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab
in patients with NMIBC who have failed prior BCG therapy.
The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1
papillary disease will be enrolled.
BCG failure is defined as persistent or recurrent disease within 12 months of completion of
adequate BCG therapy.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | December 8, 2020 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Complete response rate in patients
Primary Outcome 1 - Time Frame: 12 months
Criteria:
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
- Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS
alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub-
epithelial connective tissue) disease within 12 months of completion of adequate BCG
therapy. An assessment within 15 months can also qualify when no assessment was
performed within 12 months after completion of adequate BCG therapy.
- Adequate BCG is defined as at least 5 treatments with induction BCG followed by
at least 2 BCG treatments as reinduction or maintenance
- Ineligible for radical cystectomy or refusal of radical cystectomy
- Adequate organ function
Key Exclusion Criteria:
- Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior
organ transplant
- Prior treatment with adenovirus-based cancer therapy
- Prior therapy with or intolerant to prior checkpoint inhibitor therapy
- Clinically significant or active cardiac disease
- Active autoimmune disease
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: James Burke
Role: Principal Investigator
Affiliation: CG Oncology, Inc.
Name: Stephanie Harris
Phone: (949)-409-3700
Email: stephanie.harris@cgoncology.com
Facility | Status | Contact |
---|---|---|
BCG Oncology Phoenix, Arizona 85032 United States |
Recruiting |
Debbi Mobley debbi@bcgoncology.com |
University of California - Irvine Orange, California 92868 United States |
Recruiting |
Steven Bereta sbereta@hs.uci.edu |
Skyline Urology Sherman Oaks, California 91411 United States |
Recruiting |
Alicia Buenrostro alicia.buenrostro@skyuro.com |
Moffitt Cancer Center Tampa, Florida 33612 United States |
Recruiting |
Yazmin Rodriguez Yazmin.Rodriguez@moffitt.org |