A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
Public ClinicalTrials.gov record NCT06263231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06263231
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2024
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2028
- Last update posted
- Aug 10, 2026
2024 – 2028
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | Recruiting |
| University of California Los Angeles (UCLA) - Santa Monica Cancer Care | Santa Monica | California | 90404 | Recruiting |
| Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location | New Haven | Connecticut | 06519 | Recruiting |
| Profound Research LLC | Farmington Hills | Michigan | 48333 | Recruiting |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| The James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | Recruiting |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | 19106 | Recruiting |
| Temple University - Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06263231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06263231 live on ClinicalTrials.gov.