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Clinical Trial 21913

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04452591

Phase: Phase III
Principal Investigator: Li, Roger

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Overview

Study Title

A Phase 3 Study of CG0070 In Patients with Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Summary

To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease

Objective

Primary Objective: To determine the Complete Response rate at any time of CG0070 in patients with BCG-unresponsive carcinoma in situ (CIS) with or without concomitant high-grade Ta (TaHG) or T1 papillary disease Secondary Objectives: Assess duration of response Assess progression free survival Assess Complete Response rate at 12 months Determine cystectomy free survival Determine the frequency of progression to higher grade or higher stage disease (e.g., development of muscle invasive [T2] disease and metastatic disease) Assess the rate of delayed response beyond 3 months following treatment with CG0070 Evaluate differential response in patients with history of persistent (e.g., induction failure) and relapsed disease following past BCG treatment Evaluate the safety of CG0070 Assess overall survival

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

CG0070 (); DDM ()

Inclusion Criteria

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Have pathologically confirmed World Health Organization (WHO) grading system employed for tumor grading) high-risk NMIBC unresponsive to prior BCG therapy defined as:
  • Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy
  • Received prior adequate BCG therapy as defined as at least one of the following ("5+2" minimum exposure): At least five of six doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR At least five of six doses of an initial induction course (adequate induction) plus at least two of six doses of a second induction course.
  • Ineligible for radical cystectomy or refusal of radical cystectomy
  • Adequate organ function
  • Other criteria may apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
  • Has known upper tract or prostatic urethra malignancy
  • Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of Baseline
  • Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
  • Prior treatment with adenovirus-based cancer therapy
  • Clinically significant or active cardiac disease
  • Active autoimmune disease
  • Other exclusions may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.