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Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy

NCT03387761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-03-05

No results posted yet for this study

Summary

In cohort 1 of this study, we used an attenuated schedule of neoadjuvant ipilimumab and nivolumab. In the multicenter extension (cohort 2), 30 patients were randomized between two neoadjuvant treatment schemes, both based upon an attenuated schedule of neoadjuvant ipilimumab and nivolumab.Both cohorts are completed.

Conditions

Interventions

DRUG

Ipilimumab

For Cohort 1: * Day 1: Ipilimumab 3 mg/kg * Days 22: Ipilimumab 3 mg/kg For Cohort 2a: * Day 1: Ipilimumab 3 mg/kg * Days 22: Ipilimumab 3 mg/kg For Cohort 2b: * Day 1: Ipilimumab 1 mg/kg * Days 22: Ipilimumab 1 mg/kg

DRUG

Nivolumab

For Cohort 1: * Day 22: Nivolumab 1 mg/kg * Day 43: Nivolumab 3 mg/kg For Cohort 2a: * Days 1 and 22: Nivolumab 1 mg/kg * Day 43: Nivolumab 3 mg/kg For Cohort 2b: \- Days 1, 22 and 43: Nivolumab 3 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Michiel MS van der Heijden, Dr. · NKI-AvL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-07-19
Completion
2025-01-07

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03387761 on ClinicalTrials.gov