Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02845323
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab, while the other half will receive Nivolumab alone.

Key Dates

Start date
May 16, 2017
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab in combination with Urelumab
    Nivolumab and Urelumab combination: Nivolumab 240 mg will be administered by 1 hour intravenous infusion on day 1 and day 15 for two cycles Urelumab 8mg will be administered by 1 hour intravenous infusion on day 1 for two cycles
  • Active Comparator: Nivolumab monotherapy
    Nivolumab 240 mg will be administered by 1 hour intravenous infusion on day 1 and day 15 for two cycles

Primary Outcome Measure

Immune response to treatment with Nivolumab and Urelumab compared to Nivolumab monotherapy measured by tumor infiltrating CD8+ T cell density at cystectomy [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Institute of Urologic OncologyLos AngelesCalifornia90095-
University of Colorado Cancer CenterAuroraColorado80045-
University of ChicagoChicagoIllinois60637-
Johns Hopkins HospitalBaltimoreMaryland21205-
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in Los Angeles, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
UCLA Institute of Urologic Oncology· Los Angeles, CAUniversity of Colorado Cancer Center· Aurora, COUniversity of Chicago· Chicago, ILJohns Hopkins Hospital· Baltimore, MDColumbia University Medical Center· New York, NY

Related Studies