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

Recruiting in Palo Alto (17 mi)

Overseen byVishruth Reddy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vishruth Reddy, MD, PhD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

WOCBP must have a negative pregnancy test within 24 hours prior to the start of study drug

Hemoglobin >= 9 g/dL

Absolute neutrophil count >= 1,000/mm^3

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Exclusion Criteria

I have or had fibromyalgia, myositis, myocarditis, or myasthenia gravis.

Prisoners or subjects who are involuntarily incarcerated

I am not currently on any chemotherapy, immunotherapy, or biologic therapy for cancer.

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Treatment Details

Interventions

Definitive Surgical Resection (Procedure)
Nanoplexed Poly I:C BO-112 (Virus Therapy)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.