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

NCT04420975 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 19-000419NCI-2019-085561K08CA245181-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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; Stage I Retroperitoneal Sarcoma AJCC (American Joint Committee on Cancer) 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; 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; Pleomorphic Rhabdomyosarcoma; Resectable Dedifferentiated Liposarcoma; Resectable Soft Tissue Sarcoma; Resectable Undifferentiated Pleomorphic Sarcoma; Soft Tissue Fibrosarcoma; Spindle Cell Sarcoma; Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Synovial Sarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  AEs will be tabulated by type, severity, and the proportion of subject experiencing the event.

  study enrollment through 100 days after the last dose of study drug

Secondary Outcomes (2)

• Immune-oncologic impact of the BO-112 or the combined regimen of nivolumab and BO-112

  from the date of study drug initiation until 50 days after study drug initiation (or the date of surgery, whichever comes first)

• Pathologic treatment effect

  At time of surgery

Study Arms (1)

Treatment (BO-112, nivolumab)

EXPERIMENTAL

Patients receive BO-112 intratumorally on days 8 and 15 or 1, 8, and 15 and nivolumab IV over 30-60 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy on days 8-12 for a total of 5 fractions. Patients then undergo standard of care definitive surgical resection on day 26 to 50.

Procedure: Definitive Surgical Resection; Biological: Nanoplexed Poly I:C BO-112; Biological: Nivolumab; Radiation: Radiation Therapy

Interventions

Definitive Surgical Resection PROCEDURE

Undergo definitive surgical resection

Treatment (BO-112, nivolumab)

Nanoplexed Poly I:C BO-112 BIOLOGICAL

Given intratumorally

Also known as: BO 112, BO-112, BO112, Nanoplexed Poly IC BO-112, Nanoplexed Polyinosinic:Polycytidylic Acid BO-112

Treatment (BO-112, nivolumab)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo

Treatment (BO-112, nivolumab)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (BO-112, nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent, and assent where appropriate, must be obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Biopsy proven soft tissue sarcoma of the extremity, trunk or retroperitoneum including undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, dedifferentiated liposarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, or pleomorphic rhabdomyosarcoma. Undifferentiated pleomorphic sarcoma encompasses any of the following histologies:
• Pleomorphic undifferentiated sarcoma
• Unclassified spindle cell sarcoma
• Spindle cell sarcoma not otherwise specified
• Pleomorphic spindle cell sarcoma
• Pleomorphic fibroblastic sarcoma
• Undifferentiated high-grade pleomorphic sarcoma
• Pleomorphic sarcoma with prominent inflammation
• Pleomorphic sarcoma with giant cells
• Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
• Fibrosarcoma
• Tumor that is injectable
• Hemoglobin \>= 9 g/dL

You may not qualify if:

• Contraindications to tumor biopsy and injections (coagulopathy, known history of keloid formation, etc.)
• Women who are pregnant or breastfeeding
• Inability to give informed consent
• History of other malignancy that can interfere with interpretation of the results
• Prior irradiation in the area to be treated with preoperative radiation such that the risk of re-irradiation outweighs its benefit, according to the treating radiation oncologist
• Any condition that might interfere with the subject's participation in the study, safety, or in the evaluation of the study results
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
• Patients must not have received any live vaccine within 30 days prior to registration. Seasonal flu vaccines and other vaccines that do not contain live virus are permitted
• Any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment. Concurrent use of hormones is acceptable
• Patient must not have evidence of any clinically significant immunosuppression such as the following: primary immunodeficiency state such as severe combined immunodeficiency disease; concurrent opportunistic infection; receiving systemic immunosuppressive therapy within 28 days before enrollment with the exceptions of intranasal, topical, and inhaled corticosteroids or oral corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• Active or prior documented autoimmune disease within the past 3 years
• NOTE: Subjects with active, known or suspected autoimmune disease such as vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
• Active or prior documented inflammatory bowel disease
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• Current or history of fibromyalgia, myositis, myocarditis or myasthenia gravis

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Highlight Therapeutics: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Leiomyosarcoma; Neurofibrosarcoma; Dermatofibrosarcoma; Sarcoma; Histiocytoma, Malignant Fibrous; Sarcoma, Synovial

Interventions

BO-112; Nivolumab; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Physical Phenomena

Study Officials

• Vishruth Reddy, MD, PhD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: October 14, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)