A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)
Intensity Therapeutics, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study. Type of Participant and Disease Characteristics 2. Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), leiomyosarcoma, and undifferentiated pleomorphic sarcoma. Participant must have a pathology report indicating the diagnosis of their STS. 3. Participant must have received at least 1 line of therapy for a STS…
Interventions
- DrugINT230-6
INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.
- DrugEribulin
Eribulin IV
- DrugTrabectedin
Trabectedin infusion
- DrugPazopanib
Pazopanib pill
Locations (17)
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Sarcoma Oncology CenterSanta Monica, California
- University of California Los Angeles (UCLA) - Santa Monica Cancer CareSanta Monica, California
- Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital LocationNew Haven, Connecticut
- Profound Research LLCFarmington Hills, Michigan
- Nebraska Methodist HospitalOmaha, Nebraska