Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT04322643
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV over 30 minutes every 3 weeks
  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV over 60 minutes every 3 weeks. (if first dose is tolerated, all subsequent infusions may be delivered over 30 minutes)
  • Durvalumab — DRUG
    Durvalumab 10 mg/kg IV over 60 minutes every 2 weeks.
  • Nivolumab — DRUG
    Nivolumab 480mg IV over 30 minutes every 4 weeks
  • Avelumab — DRUG
    Avelumab 800 mg IV over 60 minutes every 2 weeks

Study Details

The purpose of this study is to test the safety and effectiveness of immunotherapy (checkpoint inhibitor therapy) in advanced bladder cancer when given intermittently. An unanswered question with the use of CPI (checkpoint inhibitor) is the duration of therapy required for optimal clinical benefit. In the absence of progressive disease or unacceptable toxicities, there are currently no specified criteria for treatment discontinuation. Strategies to reduce toxicity and maximize benefit require investigation. Thus, novel dosing schedules, early discontinuation considerations, and biomarkers of response are needed to identify patients who can sustain disease regression while off of therapy.

Key Dates

Start date
Mar 23, 2020
Status verified
Feb 2025
Primary completion
Aug 8, 2022
Completion
Apr 17, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CPI therapy
    Patients will be treated with CPI therapy for at least 24 weeks (+/- 4 weeks) as per standard of care (SOC), at which time those with a tumor burden reduction of 10% or greater will suspend CPI therapy.

Primary Outcome Measure

Number of Participants That Sustain a Response Post CPI Suspension [ Time Frame: At 36 weeks post CPI suspension ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44195-

Related coverage on Hipa.ai

Find similar trials in Cleveland, OH

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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