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A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

NCT06263231 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2025-07-29

No results posted yet for this study

Summary

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Conditions

  • Sarcoma,Soft Tissue

Interventions

DRUG

INT230-6

INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.

DRUG

Eribulin

Eribulin IV

DRUG

Trabectedin

Trabectedin infusion

DRUG

Pazopanib

Pazopanib pill

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Intensity Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christian F. Meyer, MD, PhD, MS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Spain

Study Locations

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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 NCT06263231 on ClinicalTrials.gov