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Brief Title: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

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)

INTRODUCTION

  • Org Study ID: CG2003C
  • Secondary ID: Mk3475 Keynote 935
  • NTC ID: NCT04387461
  • Sponsor: CG Oncology, Inc.

BRIEF SUMMARY

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    December 8, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate in patients

Primary Outcome 1 - Timeframe: 12 months

CONDITION

  • Non Muscle Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: James Burke

Role: Principal Investigator

Affiliation: CG Oncology, Inc.

Overall Contact

Name: James Burke

Phone: (949) 346 -4040, 516-456-1415

Email: maira.ansari@CGoncology.com, joann.horn@CGoncology.com

LOCATION

Facility Status Contact
Facility: University of California - San Diego
La Jolla, California 92093
United States
Status: Recruiting Contact: Principal Investigator
Tyler Stewart, MD

Facility: University of California - Irvine
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Steven Bereta

Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Yazmin Rodriguez

Facility: Northwestern University
Tampa, Florida 33612
United States
Status: Recruiting Contact: Principal Investigator
Roger Li, MD

Facility: Johns Hopkins Medical Institution
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Jimmy Benning

Facility: Chesapeake Urology
Hanover, Maryland 21076
United States
Status: Recruiting Contact: Principal Investigator
Joshua Meeks, MD

Facility: Mayo Clinic - Rochester
Rochester, Minnesota 55902-9823
United States
Status: Recruiting Contact: Contact
Aliya Lalji

Facility: SUNY Upstate Medical University
Syracuse, New York 13210
United States
Status: Recruiting Contact: Contact
Wendy Paxton

Facility: Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Principal Investigator
Rian Dickstein, MD

Facility: Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Status: Recruiting Contact: Contact
Tessa Kroeninger

Facility: Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact: Principal Investigator
Paras Shah, MD

Facility: Spokane Urology
Spokane, Washington 99202
United States
Status: Recruiting Contact: Contact
Jessica Chaisson

Facility: Chonnam National University Hwasun Hospital
Hwasun, 58128
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Gary Steinberg, MD

Facility: Korea University Anam Hospital
Seoul, 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Nicholas Carusone

Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Joseph Jacob, MD

Facility: The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Status: Recruiting Contact: Contact
Sara Jewell

Facility: Severance Hospital
Sinchon-dong, 50612
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Debasish Sundi, MD

Facility: Pusan National University Yangsan Hospital
Yangsan,
Korea, Republic of
Status: Recruiting Contact: Contact
Dawn Stern