MedTrace Logo

Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

NCT04278092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-05-08

No results posted yet for this study

Summary

Immune checkpoint inhibitors (CPI) such as pembrolizumab or nivolumab have been recently approved for the treatment of recurrent/metastatic head and neck cancer (HNSCC). However, only a minority of patients respond to therapy. From the clinical point of view the optimal management of patients progressing on or after CPI therapy is still a challenge. Retrospective analysis showed that HNSCC patients, who progressed on/after CPI, demonstrated an overall response rate (ORR) of up to 30% subsequent to chemotherapy +/- cetuximab treatment. It is the aim of this study to evaluate if paclitaxel plus cetuximab after first line pembrolizumab failure is an effective salvage therapy in 50 R/M HNSCC patients. The primary endpoint is ORR according to RECIST V 1.1.

Conditions

Interventions

DRUG

Paclitaxel

Paclitaxel 175 mg/m2, q21

DRUG

Cetuximab

Cetuximab 400mg/m2 loading dose followed by weekly 250mg/m2

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Thorsten Fuereder, MD · Medical University of Vienna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04278092 on ClinicalTrials.gov