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

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ClinicalTrials.gov Identifier: NCT04387461
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CG Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE May 5, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date December 13, 2021
Actual Study Start Date  ICMJE December 8, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)		 Complete response rate in patients [ Time Frame: 12 months ]
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab. [ Time Frame: 12 months ]
    Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
  • Median duration of response (DoR) [ Time Frame: 12 months ]
    Median duration of response in patients with a CR or PR
  • Median overall survival (OS) [ Time Frame: 12 months ]
    Median overall survival in months in patients
  • Median progression free survival [ Time Frame: 12 months ]
    Median duration of progression free survival of patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Muscle Invasive Bladder Cancer
Intervention  ICMJE
  • Biological: CG0070
    Engineered Oncolytic Adenovirus
  • Biological: Pembrolizumab Injection
    Immune checkpoint inhibitor, Monoclonal antibody
    Other Name: Keytruda
  • Other: n-dodecyl-B-D-maltoside
    Transduction-enhancing agent.
    Other Name: DDM
Study Arms  ICMJE Experimental: Single Arm

CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will receive 3 weekly treatments.

Beginning at Week 24, patients will receive weekly x 3 treatments every 3 months through Week 48 then every 24 weeks thereafter.

Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years.

Interventions:
  • Biological: CG0070
  • Biological: Pembrolizumab Injection
  • Other: n-dodecyl-B-D-maltoside
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)		 37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maira Ansari (949) 346 -4040 maira.ansari@CGoncology.com
Contact: Angelica Craighead 415-640-2322 angelica.craighead@cgoncology.com
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04387461
Other Study ID Numbers  ICMJE CG2003C
Mk3475 Keynote 935 ( Other Identifier: Merck )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CG Oncology, Inc.
Study Sponsor  ICMJE CG Oncology, Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: James Burke CG Oncology, Inc.
PRS Account CG Oncology, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP