Clinical Trial

Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers

Study acronym: SMART-KEY
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated February 13, 2025 (before its estimated October 16, 2025 completion). Its status may not reflect the trial's current state.
Summary
This a prospective, single-arm, multi-institutional, open label, phase 2 trial evaluating the effects of induction chemo-immunotherapy, followed by radioimmunotherapy, followed by consolidation immunotherapy in patients with locally advanced squamous cell carcinoma of the larynx who are candidates for organ preservation.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-06-28; most recent amendment 2025-02-12.
Status change: Recruiting → Active, Not Recruiting 2023-10-04
Status change: Not Yet Recruiting → Recruiting 2022-02-14
Trial Details
NCT Number NCT04943445
Lead Sponsor Latin American Cooperative Oncology Group
Collaborators: Merck Sharp & Dohme LLC
Conditions Squamous Cell Carcinoma of Larynx
Enrollment 43 participants
Start Date 2022-02-22
Primary Completion 2025-10-16 (estimated)
Study Completion 2025-10-16 (estimated)
Updated on ClinicalTrials.gov 2025-02-13