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NCT05836571 · ClinicalTrials.gov registry record · Phase 2

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

A Phase 2 study of Metastatic Soft Tissue Sarcoma and Unresectable Leiomyosarcoma, sponsored by National Cancer Institute LAO.

Active
Registry status
Phase 2
Development phase
66
Enrollment target
20
Study locations

NCT05836571 is a Phase 2 study of Metastatic Soft Tissue Sarcoma and Unresectable Leiomyosarcoma that is active but no longer recruiting, run by National Cancer Institute LAO. The registered enrollment target is 66 participants, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT05836571, a Phase 2 study of Metastatic Soft Tissue Sarcoma and Unresectable Leiomyosarcoma, is active but no longer recruiting, sponsored by National Cancer Institute LAO.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
66 participants
Enrollment target
20
Study locations

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

Metastatic Soft Tissue Sarcoma Unresectable Leiomyosarcoma Unresectable Liposarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Unresectable Undifferentiated Pleomorphic Sarcoma Locally Advanced Extraskeletal Myxoid Chondrosarcoma Locally Advanced Leiomyosarcoma Locally Advanced Liposarcoma Locally Advanced Undifferentiated Pleomorphic Sarcoma Locally Advanced Unresectable Soft Tissue Sarcoma

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

FieldValue
Enrollment Target 66 participants
Start Date 2023-10-25
Est. Completion 2026-05-15
Phase Phase 2

Sponsor

National Cancer Institute LAO

2 total trials

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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, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (51% lower). The listed sponsor is National Cancer Institute LAO, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT05836571 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Connecticut, Maryland.

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.

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).

Who is sponsoring clinical trial NCT05836571?

This trial is sponsored by National Cancer Institute LAO, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.