Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)

  • STATUS
    Not Recruiting
  • End date
    Jun 14, 2023
  • participants needed
    37
  • sponsor
    CG Oncology, Inc.
Updated on 14 September 2022

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.

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.

Details
Condition Non Muscle Invasive Bladder Cancer
Treatment Pembrolizumab Injection, CG0070, n-dodecyl-B-D-maltoside
Clinical Study IdentifierNCT04387461
SponsorCG Oncology, Inc.
Last Modified on14 September 2022

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