Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma

Summary

This phase I trial studies the side effects of BO-112 when given together with nivolumab before surgery in treating patients with soft tissue sarcoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with BO-112, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab and BO-112 before surgery may work better in treating patients with soft tissue sarcoma compared to nivolumab alone.

Conditions

• Leiomyosarcoma
• Malignant Peripheral Nerve Sheath Tumor
• Myxofibrosarcoma
• Pleomorphic Rhabdomyosarcoma
• Resectable Dedifferentiated Liposarcoma
• Resectable Soft Tissue Sarcoma
• Resectable Undifferentiated Pleomorphic Sarcoma
• Soft Tissue Fibrosarcoma
• Spindle Cell Sarcoma
• Stage I Retroperitoneal Sarcoma AJCC (American Joint Committee on Cancer) v8
• Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IA Retroperitoneal Sarcoma AJCC v8
• Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IB Retroperitoneal Sarcoma AJCC v8
• Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage II Retroperitoneal Sarcoma AJCC v8
• Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage III Retroperitoneal Sarcoma AJCC v8
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIA Retroperitoneal Sarcoma AJCC v8
• Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIB Retroperitoneal Sarcoma AJCC v8
• Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Storiform-Pleomorphic Malignant Fibrous Histiocytoma
• Synovial Sarcoma
• Undifferentiated High Grade Pleomorphic Sarcoma of Bone
• Undifferentiated Pleomorphic Sarcoma
• Undifferentiated Pleomorphic Sarcoma With Osteoclast-Like Giant Cells
• Undifferentiated Pleomorphic Sarcoma, Inflammatory Variant
• Undifferentiated Spindle Cell Sarcoma

Interventions

PROCEDURE

Definitive Surgical Resection

Undergo definitive surgical resection

BIOLOGICAL

Nanoplexed Poly I:C BO-112

Given intratumorally

BIOLOGICAL

Nivolumab

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Highlight Therapeutics

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Vishruth Reddy, MD, PhD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-14

Primary Completion

2027-01-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States

Study Locations