NCT05041127

Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

Detailed description

Primary Objective: • To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1. Secondary Objectives: * To evaluate response rate according to Choi criteria * To evaluate the safety and tolerability of cetuximab for chordoma patients * To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median). * To evaluate the ratio of PFS on study compared to PFS from prior treatment

Conditions

• Chordoma
• Metastatic Chordoma
• Unresectable Chordoma

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Given IV
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-05-27
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-09-10
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study