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

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

• 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

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of urine and/or blood sample

DRUG

Cabozantinib

Given PO

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

• National Cancer Institute LAO

  lead UNKNOWN

Principal Investigators

• A P Chen · National Cancer Institute LAO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-25

Primary Completion

2026-05-15

Completion

2026-05-15

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations