Clinical Trials /

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

NCT04387461

Description:

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.

Related Conditions:
  • Bladder Urothelial Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: CG2003C
  • SECONDARY ID: Mk3475 Keynote 935
  • NCT ID: NCT04387461

Conditions

  • Non Muscle Invasive Bladder Cancer

Interventions

DrugSynonymsArms
CG0070Single Arm
Pembrolizumab InjectionKeytrudaSingle Arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalCG0070 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.
  • CG0070
  • Pembrolizumab Injection

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate in patients
Time Frame:12 months
Safety Issue:
Description:Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

Secondary Outcome Measures

Measure:Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Time Frame:12 months
Safety Issue:
Description:Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Measure:Median duration of response (DoR)
Time Frame:12 months
Safety Issue:
Description:Median duration of response in patients with a CR or PR
Measure:Median overall survival (OS)
Time Frame:12 months
Safety Issue:
Description:Median overall survival in months in patients
Measure:Median progression free survival
Time Frame:12 months
Safety Issue:
Description:Median duration of progression free survival of patients

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CG Oncology, Inc.

Trial Keywords

  • high-grade Ta papillary disease
  • high-grade T1 papillary disease
  • carcinoma in situ
  • Bacillus-Calmette-Guerin Unresponsive

Last Updated

December 10, 2020