Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Tyler Stewart, MD
Photo of Tyler Stewart
Tyler Stewart

Description

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.

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)

Details

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.

Keywords

Non Muscle Invasive Bladder Cancer high-grade Ta papillary disease high-grade T1 papillary disease carcinoma in situ Bacillus-Calmette-Guerin Unresponsive Urinary Bladder Neoplasms Pembrolizumab Pembrolizumab Injection n-dodecyl-B-D-maltoside

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California - San Diego accepting new patients
    La Jolla California 92093 United States
  • University of California - Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UCSD

  • Tyler Stewart, MD
    Assistant Professor Of Clinical, Medicine. Authored (or co-authored) 15 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CG Oncology, Inc.
ID
NCT04387461
Phase
Phase 2
Study Type
Interventional
Last Updated