A Study to Analyze CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer

Overview

About this study

The purpose of this study is to evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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):

1. At least five of six doses of an initial induction course (adequate induction)
plus at least two of three doses of maintenance therapy, OR

2. 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

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

Eligibility last updated 5/11/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Tyson, M.D., M.P.H.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Lyon, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.
CLS-20515423

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