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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

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

Pathologic treatment effect

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220