Phase 3 Study Comparing Intratumoral INT230-6 With Standard US Treatments in Adults With Advanced or Metastatic Soft Tissue Sarcomas

What this Trial Is About

Researchers are evaluating the overall survival of adults with unresectable or metastatic soft tissue sarcomas, including liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma. The study focuses on participants whose disease progressed after receiving up to two standard treatments, including an anthracycline-based regimen unless contraindicated. This Phase 3 randomized trial compares an investigational drug combination administered directly into tumors with the current United States standard of care therapies. Participants receive INT230-6, a fixed combination of cisplatin, vinblastine, and SHAO, injected into tumors every two weeks for up to five sessions. After completing this initial treatment phase, they enter a maintenance phase lasting up to 22 months, during which new or previously treated lesions may be reinjected every 12 weeks. The comparison group receives standard therapies based on sarcoma subtype and investigator choice, including pazopanib daily, trabectedin infusion every three weeks, or eribulin IV on days 1 and 8 every three weeks. Throughout the study, participants are monitored for overall survival up to two years following randomization. Researchers will assess survival rates and compare the effectiveness of INT230-6 with standard therapies. Participants undergo regular evaluations, including imaging to measure tumors and laboratory tests to assess organ function and safety. The study aims to provide detailed information on treatment outcomes and safety in this population over the trial duration, which extends until December 2028.

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