Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
Public ClinicalTrials.gov record NCT05836571. 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
Randomized Phase 2 Study of Cabozantinib, Ipilimumab, and Nivolumab in Patients With Soft Tissue Sarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial compares the effect of immunotherapy with ipilimumab and nivolumab alone to their combination with cabozantinib in treating patients with soft tissue sarcoma that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Adding cabozantinib to the combination of ipilimumab and nivolumab may be better in stopping or slowing the growth of tumor compared to ipilimumab and nivolumab alone in patients with advanced soft tissue sarcoma.
Study identification
- NCT ID
- NCT05836571
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
- Locally Advanced Extraskeletal Myxoid Chondrosarcoma
- Locally Advanced Leiomyosarcoma
- Locally Advanced Liposarcoma
- Locally Advanced Undifferentiated Pleomorphic Sarcoma
- Locally Advanced Unresectable Soft Tissue Sarcoma
- Metastatic Soft Tissue Sarcoma
- Metastatic Undifferentiated Pleomorphic Sarcoma
- Unresectable Leiomyosarcoma
- Unresectable Liposarcoma
- Unresectable Undifferentiated Pleomorphic Sarcoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Cabozantinib Drug
- Computed Tomography Procedure
- Ipilimumab Biological
- Magnetic Resonance Imaging Procedure
- Nivolumab Biological
Procedure · Drug · Biological
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
- Oct 25, 2023 (Actual)
- Primary completion
- May 15, 2028 (Estimated)
- Completion
- May 15, 2028 (Estimated)
- Last update posted
- Oct 9, 2026
2023 – 2028
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| Keck Medicine of USC Koreatown | Los Angeles | California | 90020 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | 92663 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05836571, 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 Oct 9, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05836571 live on ClinicalTrials.gov.