NCT04943445View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

February 22, 2022

Primary Completion Date

October 16, 2025

Study Completion Date

October 16, 2025

Conditions
Squamous Cell Carcinoma of Larynx
Interventions
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

Trial Locations (10)

60.335-480

CRIO - Centro Regional Integrado de Oncologia, Fortaleza

59.062-000

Liga Norte Riograndense Contra o Câncer, Natal

90.610-000

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre

14.784-400

Hospital de Amor de Barretos, Barretos

14.015-010

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto

15.090-000

FUNFARME - Hospital de Base de São José do Rio Preto, São José do Rio Preto

20.230-130

INCA - Instituto Nacional de Câncer, Rio de Janeiro

01.246-000

ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo

01.323-030

BP - A Beneficência Portuguesa de São Paulo, São Paulo

01.509-001

A.C. Camargo Cancer Center, São Paulo

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER