Study Summary
This trial is testing the side effects of a combination of two drugs, one of which helps the body's immune system attack cancer cells, before surgery in patients with a type of cancer that can be removed surgically.
Eligible Conditions
- Soft Tissue Sarcoma
- Stage I Retroperitoneal Sarcoma
- Malignant Fibrous Histiocytoma
- Undifferentiated Spindle Cell Sarcoma
- Synovial Sarcoma
- Stage IB Soft Tissue Sarcoma
- Stage IIIA Retroperitoneal Sarcoma
- Stage II Retroperitoneal Sarcoma
- Stage I Soft Tissue Sarcoma
- Undifferentiated Pleomorphic Sarcoma With Osteoclast-Like Giant Cells
- Soft Tissue Fibrosarcoma
- Spindle Cell Sarcoma
- Undifferentiated Pleomorphic Sarcoma, Inflammatory Variant
- Undifferentiated Pleomorphic Sarcoma
- Stage IB Retroperitoneal Sarcoma
- Stage II Soft Tissue Sarcoma
- Pleomorphic Rhabdomyosarcoma
- Dedifferentiated Liposarcoma
- Malignant Peripheral Nerve Sheath Tumor
- Myxofibrosarcoma
- Stage III Soft Tissue Sarcoma
- Resectable Undifferentiated Pleomorphic Sarcoma
- Stage IA Retroperitoneal Sarcoma
- Stage IIIA Soft Tissue Sarcoma
- Stage III Retroperitoneal Sarcoma
- Stage IIIB Soft Tissue Sarcoma
- Undifferentiated High Grade Pleomorphic Sarcoma of Bone
- Stage IIIB Retroperitoneal Sarcoma
- Leiomyosarcoma
- Stage IA Soft Tissue Sarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: At time of surgery
At time of surgery
Pathologic treatment effect
Before-surgery
Frequency and severity of adverse events (AEs) and dose limiting toxicities (DLTs)
Glucan (BO)
Day 50
Immune-oncologic impact of the BO-112 or the combined regimen of nivolumab and BO-112
Day 100
Incidence of adverse events (AEs)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (BO-112, nivolumab)
1 of 1
Experimental Treatment
14 Total Participants · 1 Treatment Group
Primary Treatment: Definitive Surgical Resection · No Placebo Group · Phase 1
Treatment (BO-112, nivolumab)Experimental Group · 5 Interventions: Definitive Surgical Resection, Nanoplexed Poly I:C BO-112, Immunotherapeutic Agent, Nivolumab, Radiation Therapy · Intervention Types: Procedure, Biological, Drug, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at time of surgery
Who is running the clinical trial?
Highlight TherapeuticsIndustry Sponsor
5 Previous Clinical Trials
149 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,102 Previous Clinical Trials
41,145,972 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
339 Previous Clinical Trials
21,713 Total Patients Enrolled
Anusha KalbasiPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Vishruth Reddy, MD, PhDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:A diagnosis of spindle cell sarcoma is not yet classified
You must obtain written informed consent and assent from the subject prior to performing any protocol-related procedures, including screening evaluations.
The tumor must be high-grade pleomorphic sarcoma.
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Conditions
Cancer Related
Treatments