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Virus Therapy

Pre-Surgery Nivolumab + BO-112 for Soft Tissue Sarcoma

Phase 1
Waitlist Available
Led By Anusha Kalbasi
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy proven soft tissue sarcoma of the extremity, trunk or retroperitoneum including specific histologies
Serum creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min
Must not have
Current or history of fibromyalgia, myositis, myocarditis or myasthenia gravis
Any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery
Awards & highlights

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.

Who is the study for?
This trial is for adults with certain types of soft tissue sarcoma that can be surgically removed. Participants must have a specific level of blood cells, not be breastfeeding, agree to use effective contraception methods if applicable, and provide consent. They should not have received live vaccines recently or have any condition that could affect their participation.Check my eligibility
What is being tested?
The trial is testing the combination of BO-112 and nivolumab given before surgery compared to nivolumab alone. These are immunotherapies designed to help the immune system fight cancer by stopping tumor growth and spread. The goal is to see if this combo works better in treating soft tissue sarcoma.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, fatigue, allergic reactions at infusion sites, changes in blood counts leading to increased infection risk, and possibly other organ-specific issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of sarcoma found in my limbs, trunk, or behind the abdomen.
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My kidney function is within the normal range.
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I am fully active or can carry out light work.
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My tumor can be reached and treated with an injection.
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My platelet count is healthy and I don't need blood transfusions.
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I am a man using contraception while on nivolumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had fibromyalgia, myositis, myocarditis, or myasthenia gravis.
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I am not currently on any chemotherapy, immunotherapy, or biologic therapy for cancer.
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I have or had inflammatory bowel disease.
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I have another cancer that could affect study results.
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I cannot have tumor biopsies or injections due to health risks.
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I am not pregnant or breastfeeding.
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I have or had lung inflammation.
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I have had radiation treatment in the area that needs preoperative radiation.
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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of study drug initiation until 50 days after study drug initiation (or the date of surgery, whichever comes first)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of study drug initiation until 50 days after study drug initiation (or the date of surgery, whichever comes first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Immune-oncologic impact of the BO-112 or the combined regimen of nivolumab and BO-112
Pathologic treatment effect

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (BO-112, nivolumab)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
27,934 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,387 Total Patients Enrolled
Highlight TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
195 Total Patients Enrolled

Media Library

Nanoplexed Poly I:C BO-112 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04420975 — Phase 1
Soft Tissue Sarcoma Research Study Groups: Treatment (BO-112, nivolumab)
Soft Tissue Sarcoma Clinical Trial 2023: Nanoplexed Poly I:C BO-112 Highlights & Side Effects. Trial Name: NCT04420975 — Phase 1
Nanoplexed Poly I:C BO-112 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04420975 — Phase 1
~2 spots leftby Jan 2025