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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387461
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Muscle Invasive Bladder Cancer Biological: CG0070 Biological: Pembrolizumab Injection Other: n-dodecyl-B-D-maltoside Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Median duration of response (DoR) [ Time Frame: 12 months ]
    Median duration of response in patients with a CR or PR

  3. Median overall survival (OS) [ Time Frame: 12 months ]
    Median overall survival in months in patients

  4. Median progression free survival [ Time Frame: 12 months ]
    Median duration of progression free survival of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387461


Contacts
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Contact: Stephanie Harris (949)-409-3700 stephanie.harris@cgoncology.com

Sponsors and Collaborators
CG Oncology, Inc.
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: James Burke CG Oncology, Inc.
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Responsible Party: CG Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04387461    
Other Study ID Numbers: CG2003C
Mk3475 Keynote 935 ( Other Identifier: Merck )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CG Oncology, Inc.:
high-grade Ta papillary disease
high-grade T1 papillary disease
carcinoma in situ
Bacillus-Calmette-Guerin Unresponsive
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents