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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of surgery

Awards & highlights

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.

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.

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

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

~4750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,061 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,139 Total Patients Enrolled

Highlight TherapeuticsIndustry Sponsor

5 Previous Clinical Trials

135 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does this research compare to other similar trials?

"As of now, 49 nations are home to 2356 cities with 717 active clinical trials for Definitive Surgical Resection. The first such study was launched in 2012 by Ono Pharmaceutical Co. Ltd and it included 659 patients across the Phase 1 & 2 drug approval stage. In the 8 years since then, 358 trials have been successfully carried out."

Answered by AI

Has this technique of Definitive Surgical Resection been tested in other scientific trials?

"Presently, there are 717 active research trials researching Definitive Surgical Resection. Of these studies, 82 have progressed to Phase 3. These investigations are primarily based in Basel, BE; yet 40290 medical centers across the globe are participating in this investigation."

Answered by AI

How secure are the results of Definitive Surgical Resection for patients?

"Due to the limited data supporting its effectiveness and safety, Definitive Surgical Resection was rated a 1 on our team's scale."

Answered by AI

In what condition is Definitive Surgical Resection commonly employed?

"Definitive Surgical Resection is commonly used to seek out and eliminate malignant neoplasms. However, it also has a role in the management of diseases such as metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."

Answered by AI

Are participants currently enrolling in this research endeavor?

"This research project, which was posted on October 29th 2020 and last modified on November 18th 2022 is not currently recruiting participants. However, there are 1,229 other clinical trials actively searching for applicants at this time."

Answered by AI

How large is the cohort of participants involved in this experiment?

"This trial is no longer open for enrollment. It was published on October 29th 2020 and its last edit was made on November 18th 2022. Fortunately, there are 512 studies that currently require participants with leiomyosarcoma and 717 trials actively admitting those seeking Definitive Surgical Resection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04420975.

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