Moffitt Cancer Center: Clinical Trial 20711

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Clinical Trial 20711

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04387461

Phase: Phase II
Prinicipal Investigator: Roger Li

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study 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)

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.

Objective

Primary: Evaluate the complete response rate at 12 months of CG0070 combined with pembrolizumab in patients with BCG unresponsive CIS with or without concomitant high-grade Ta or T1 papillary disease

Treatments

Therapies

Medications

CG0070 (); DDM (); Pembrolizumab (Keytruda)

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

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

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.