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Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
NCT05836571 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Cabozantinib
- BIOLOGICAL Ipilimumab
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center — Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
- Keck Medicine of USC Koreatown — Los Angeles
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- USC Norris Oncology/Hematology-Newport Beach — Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford
- Yale University — New Haven
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
Maryland
- National Cancer Institute Developmental Therapeutics Clinic — Bethesda
- National Institutes of Health Clinical Center — Bethesda
Missouri
- Washington University School of Medicine — St Louis
- Siteman Cancer Center-South County — St Louis
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Florida
- University of Florida Health Science Center - Gainesville — Gainesville
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York
North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-10-25 |
| Est. Completion | 2026-05-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05836571
The ClinicalTrials.gov registry entry for NCT05836571 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute LAO, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05836571 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Connecticut, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05836571 about?
NCT05836571 is a clinical study titled "Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma". 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). Immuno...
What is the current status of trial NCT05836571?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2023-10-25. Estimated completion is 2026-05-15.
What conditions does trial NCT05836571 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Unresectable Leiomyosarcoma, Unresectable Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05836571?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Cabozantinib (DRUG), Ipilimumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05836571?
This trial is sponsored by National Cancer Institute LAO, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05836571 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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