Pre-operative Immunotherapy in Stage II-III Urothelial Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT04871594
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients. This study can be adapted or expanded based on the results obtained.

Key Dates

Start date
Aug 23, 2021
Status verified
Mar 2025
Primary completion
Jun 2, 2023
Completion
Dec 30, 2024

Study Design

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

Arms

  • Experimental: Nivolumab monotherapy
    Day 1: nivolumab 240 mg Day 22: nivolumab 240 mg Day 43: nivolumab 240 mg

Primary Outcome Measure

Feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients [ Time Frame: At 12 weeks ]

Related Studies