Primary Outcomes:

Primary Outcome 1 - Measure: Event Free Survival (EFS)

Primary Outcome 1 - Time Frame: approximately 3 years

Condition:

• Bladder Cancer

Eligibility

Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com.

Inclusion:

- Predominant histologic component (> 50%) must be urothelial (transitional cell)
carcinoma

- Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as
BCG unresponsive

- Histologically confirmed persistent or recurrent high-risk non-muscle-invasive
urothelial carcinoma (UC)

- Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6
doses)

- Sufficient tissue for both biomarker analysis and central pathology review committee
(PRC) confirmation of diagnosis

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

- Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to
follow contraceptive requirements

Exclusion Criteria

- Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic
UC

- UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters)
within 24 months of enrollment

- UC and/or CIS in the prostatic urethra within 12 months of enrollment

- Prior surgery (other than transurethral resection of the bladder tumor
(TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic
chemotherapy or immunotherapy for bladder cancer or UC

Other inclusion/exclusion criteria apply.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No