Clinical trial NCT04387461: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Official title: A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Muscle Invasive Bladder Cancer
Keywords: high-grade Ta papillary disease
high-grade T1 papillary disease
carcinoma in situ
Bacillus-Calmette-Guerin Unresponsive
Lead sponsor: CG Oncology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-05-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* 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

Primary outcomes:
measure: Complete response rate in patients
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
timeFrame: 12 months
measure: Median duration of response (DoR)
timeFrame: 12 months
measure: Median overall survival (OS)
timeFrame: 12 months
measure: Median progression free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Orange
country: United States
facility: University of California - Irvine
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Tampa
country: United States
facility: Northwestern University
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution
state: Maryland
city: Hanover
country: United States
facility: Chesapeake Urology
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: New York University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Sinchon-dong
country: Korea, Republic of
facility: Severance Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: