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BRIEF TITLE: CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

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)


  • Org Study ID: CG2003C
  • Secondary ID: Mk3475 Keynote 935
  • NCT ID: NCT04387461
  • NCT Alias:
  • Sponsor: CG Oncology, Inc. - Industry
  • Source: 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.

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

Primary Outcomes:

Primary Outcome 1 - Measure: Complete response rate in patients

Primary Outcome 1 - Time Frame: 12 months

Condition:

  • Non Muscle Invasive Bladder Cancer

Eligibility

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
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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: Stephanie Harris

Phone: (949)-409-3700

Email: stephanie.harris@cgoncology.com

Locations

Facility Status Contact
BCG Oncology
Phoenix, Arizona 85032
United States
Recruiting Debbi Mobley

University of California - San Diego
La Jolla, California 92093
United States
Not yet recruiting Michelle Padilla

University of California - Irvine
Orange, California 92868
United States
Recruiting Steven Bereta

Skyline Urology
Sherman Oaks, California 91411
United States
Recruiting Alicia Buenrostro

Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Yazmin Rodriguez

Northwestern University
Tampa, Florida 33612
United States
Not yet recruiting Jimmy Benning

Johns Hopkins Medical Institution
Baltimore, Maryland 21287
United States
Not yet recruiting Aliya Lalji

Chesapeake Urology
Hanover, Maryland 21076
United States
Not yet recruiting Wendy Paxton

Spectrum Health
Grand Rapids, Michigan 49503
United States
Not yet recruiting Ross Busman

Mayo Clinic - Rochester
Rochester, Minnesota 55902-9823
United States
Not yet recruiting Tessa Kroeninger

New York University
New York, New York 10003
United States
Not yet recruiting Jessica Chaisson

SUNY Upstate Medical University
Syracuse, New York 13210
United States
Not yet recruiting Nicholas Carusone

Ohio State University
Columbus, Ohio 43210
United States
Not yet recruiting Sara Jewell

Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Recruiting Dawn Stern

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Not yet recruiting Rutika Kokate

Spokane Urology
Spokane, Washington 99202
United States
Recruiting Amy Bardwell

Chonnam National University Hwasun Hospital
Hwasun, 58128
Korea, Republic of
Not yet recruiting Mi Young Jung

Korea University Anam Hospital
Seoul, 02841
Korea, Republic of
Not yet recruiting Seok Young Kim

Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Not yet recruiting Song Hee Kim

The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Not yet recruiting Hyo Jung Park

Pusan National University Yangsan Hospital
Yangsan, 50612
Korea, Republic of
Not yet recruiting Yu Jin Jung