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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

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