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

NCT04943445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-02-13

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • William Nassib William Junior · Latin American Cooperative Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2025-10-16
Completion
2025-10-16

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943445 on ClinicalTrials.gov