Active — Not RecruitingPhase 1

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

United States14 participantsStarted 2020-10-14

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent, and assent where appropriate, must be obtained from the subject prior to performing any protocol-related procedures, including screening evaluations * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Biopsy proven soft tissue sarcoma of the extremity, trunk or retroperitoneum including undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, dedifferentiated liposarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, or pleomorphic rhabdomyosarcoma. Undifferentiated pleomorphic sarcoma encompasses any of the following histologies: * Pleomorphic undifferentiated sarcoma * Unclassified spindle cell sarcoma * Spindle cell sarcoma not otherwise specified * Pleomorphic spindle cell sarcoma * Pleomorphic fibroblastic sarcoma * Undifferentiated high-grade pleomorphic sarcoma * Pleomorphic sarcoma with prominent inflammation * Pleomorphic sarcoma with giant cells * Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes) * Fibrosarcoma * Tumor that is injectable * Hemoglobin \>= 9 g/dL * Absolute neutrophil count \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 and transfusion independent * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal (ULN) * Serum creatinine \< 1.5 x ULN or creatinine clearance \> 60 mL/min for patients with creatinine levels above ULN (as deter…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events (AEs)

Timeframe: study enrollment through 100 days after the last dose of study drug

Trial details

NCT IDNCT04420975

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Leiomyosarcoma trials