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Intensity Therapeutics / IT-03

Trial Overview

Official Title

A Multicenter, Randomized, Phase III Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With Standard of Care in Adult participants With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas - (THE INVINCIBLE-3 TRIAL)

 

Study Purpose

To evaluate the effectiveness of IT-03 compared to the usual treatment of pazopanib, trabectedin or eribulin

 

Diagnosis

Non-uterine leiomyosarcoma; liposarcoma; or pleomorphic sarcoma

Eligibility

Locally recurrent, inoperable or metastatic with disease progression following one to two prior regimens of treatment. 

 

Intervention

Experimental arm: Tumor injected INT230-6 by interventional radiologist

Control arm: standard of care (usual treatment) – pazopanib, trabectedin or eribulin

Key Participation Requirements
Gender
Male or Female
Age
18 years and Older
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
IT-03