Trial intelligence / Profile preview

Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer

NCT05406713Phase 2

Key facts

Status: Active, not recruiting
Start: Jul 2022
Primary completion: Jan 2027
Countries: 1
Modality: Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes

Drugs: pembrolizumab
Conditions: muscle-invasive bladder cancer (MIBC)

Overview

Phase 2, open-label, single-arm trial of pembrolizumab in muscle-invasive bladder cancer (MIBC). Primary endpoints: Clinical Complete Response Rate at 2 years and Benefit from Treatment at 2 years. Started Jul 2022; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental Group
Neoadjuvant Pembrolizumab followed by Maintenance/Adjuvant Pembrolizumab

Who it enrols

Adults with cT2-3N0M0 muscle-invasive urothelial bladder cancer who have undergone maximal TURBT, decline or are ineligible for cisplatin-based neoadjuvant chemotherapy, with adequate organ function and no prior systemic therapy for this cancer.

Endpoints

Primary

Clinical Complete Response Rate2 years
Benefit from Treatment2 years

Secondary

Adverse Events6 months
Positive Predictive Value between PD-L1 Expression and clinical complete response2 years
Positive Predictive Value between TMB and clinical complete response2 years
Metastasis Free Survival2 years
Bladder-intact Event Free Survival2 years
Overall Survival2 years
Bladder-Intact Overall Survival2 years
Invasive Bladder Recurrence Free Survival2 years

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