NCT04943445

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

A Single-arm, Multi-institutional, Phase 2 Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of Larynx

Interventions

Type	Name	Description
DRUG	carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles	Patients without disease progression will proceed to the concurrent radioimmunotherapy phase of the trial.
RADIATION	Concurrent radio-immunotherapy: radiation therapy given concurrently with pembrolizumab 200 mg i.v. on day 1, every 21 days for 3 cycles.	Patients without disease progression will proceed to the consolidation immunotherapy phase of the trial.
DRUG	Consolidation immunotherapy: pembrolizumab 200 mg i.v. on day 1, every 21 days for 11 doses.	Consolidation immunotherapy

Timeline

• Start date: 2022-02-22
• Primary completion: 2025-10-16
• Completion: 2025-10-16
• First posted: 2021-06-29
• Last updated: 2025-02-13

Locations

10 sites across 1 country: Brazil