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Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

NCT04322643 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-02-25

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV over 30 minutes every 3 weeks

DRUG

Atezolizumab

Atezolizumab 1200 mg IV over 60 minutes every 3 weeks. (if first dose is tolerated, all subsequent infusions may be delivered over 30 minutes)

DRUG

Durvalumab

Durvalumab 10 mg/kg IV over 60 minutes every 2 weeks.

DRUG

Nivolumab

Nivolumab 480mg IV over 30 minutes every 4 weeks

DRUG

Avelumab

Avelumab 800 mg IV over 60 minutes every 2 weeks

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Moshe Ornstein, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2022-08-08
Completion
2023-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322643 on ClinicalTrials.gov