A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

  • Interventional
  • Recruiting
  • NCT03519256
Eligibility Details Visit Clinicaltrials.gov

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

        Inclusion Criteria:

         - Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta high-grade lesions

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

         - Eastern Cooperative Oncology Group (ECOG) performance status 0-1

        Exclusion Criteria:

         - Sign of locally advanced disease or metastatic bladder cancer

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

         - Prior immuno-oncology therapy

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT03519256

IRB#IRB18-0160

Lead SponsorBristol-Myers Squibb

Lead PhysicianRandy Sweis

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting