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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04420975
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Leiomyosarcoma
  • Malignant Peripheral Nerve Sheath Tumor
  • Myxofibrosarcoma
  • Pleomorphic Rhabdomyosarcoma
  • Resectable Dedifferentiated Liposarcoma
  • Resectable Soft Tissue Sarcoma
  • Resectable Undifferentiated Pleomorphic Sarcoma
  • Soft Tissue Fibrosarcoma
  • Spindle Cell Sarcoma
  • Stage I Retroperitoneal Sarcoma AJCC (American Joint Committee on Cancer) v8
  • Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IA Retroperitoneal Sarcoma AJCC v8
  • Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IB Retroperitoneal Sarcoma AJCC v8
  • Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage II Retroperitoneal Sarcoma AJCC v8
  • Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage III Retroperitoneal Sarcoma AJCC v8
  • Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IIIA Retroperitoneal Sarcoma AJCC v8
  • Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IIIB Retroperitoneal Sarcoma AJCC v8
  • Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Storiform-Pleomorphic Malignant Fibrous Histiocytoma
  • Synovial Sarcoma
  • Undifferentiated High Grade Pleomorphic Sarcoma of Bone
  • Undifferentiated Pleomorphic Sarcoma
  • Undifferentiated Pleomorphic Sarcoma With Osteoclast-Like Giant Cells
  • Undifferentiated Pleomorphic Sarcoma, Inflammatory Variant
  • Undifferentiated Spindle Cell Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Definitive Surgical Resection — PROCEDURE
    Undergo definitive surgical resection
  • Nanoplexed Poly I:C BO-112 — BIOLOGICAL
    Given intratumorally
  • Nivolumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo radiation therapy

Study Details

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.

Key Dates

Start date
Oct 14, 2020
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (BO-112, nivolumab)
    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.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: study enrollment through 100 days after the last dose of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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