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SARC038: A Phase 2 Study of Regorafenib in Combination With Nivolumab in Patients With Refractory or Recurrent Osteosarcoma

The combination of an anti-VEGF agent with an immune checkpoint inhibitor has shown efficacy in various cancer types, potentially through increasing immune infiltrate by normalizing vasculature and decreasing T-cell suppression. REGOBONE and SARC024 trials showed an improvement in progression-free survival (PFS) with regorafenib compared to placebo. In SARC038, the hypothesis is that by adding nivolumab, a PD-1 inhibitor, to regorafenib may further improve PFS compared to regorafenib alone.

The SARC038 clinical trial will open at Levine Children’s Hospital and Levine Cancer Institute in Charlotte, NC shortly.

SARC038 Clinical Trial Details

Prospective Observational Trial Utilizing Liquid Biopsy Techniques for Treatment Response and Disease Surveillance in Resectable Non-Metastatic Intermediate- and High-grade Sarcoma Patients

This prospective, observational study of patients with intermediate- and high-grade bone and soft tissue sarcomas will evaluate the use of a sarcoma-specific liquid biopsy circulating tumor DNA technique capable of identifying molecular patterns in sarcoma patients’ blood samples and correlating them with treatment response and disease progression. Blood specimens will be collected at various time points during a patient’s disease from diagnosis to up to two years post-treatment. Plasma samples will be sequenced to identify structural variants and targeted translocations that are specific to sarcoma. The molecular patterns identified by liquid biopsy will be compared to standard surveillance methods utilized to detect treatment response and distant metastasis. The results of this study will provide valuable information that will allow for more effective patient management and a greater understanding of the underlying mechanisms driving sarcomas.

Identification of Novel Prognostic and Therapeutic Biomarkers of Synovial Sarcoma through Comprehensive Molecular Analysis

Sarcomas are a rare and aggressive group of cancers that arise from connective tissues such as muscle, fat, nerve, tendon, bone, and cartilage. Despite their rarity, over 100 different subtypes have been described. Synovial sarcoma is one subtype of sarcoma that often occurs in the soft tissues of the lower extremities of young adults. Synovial sarcoma is characterized by a specific translocation, which is an inappropriate joining, of the X chromosome with chromosome 18. Research has shown that this translocation affects the system that controls the physical packaging and orientation of the chromosomes within the nucleus – also known as the epigenome. These ‘epigenetic’ changes flip the on/off state of countless genes, resulting in the cell becoming the synovial sarcoma cancer. While this basic mechanism has been understood, there is very little research into how those changes impact the prognosis or treatability of each different case of synovial sarcoma. At our institution, we have over 70 synovial sarcoma specimens that have been carefully preserved over the last few decades. The purpose for this study is to perform comprehensive sequencing of these specimens and compare to patient outcomes to characterize how these changes affect prognosis and help to uncover avenues for new future treatments.

LCI-SAR-STS-PEM-001: A pilot study evaluating the safety, tolerability and efficacy of doxorubicin and pembrolizumab in patients with metastatic or unresectable soft tissue sarcoma

As part of the LCI-SAR-STS-PEM-001 study, Levine will evaluate the correlation between immunotherapy markers (PD-L1 expression levels) and the clinical effectiveness of pembrolizumab, investigate other biomarkers that may correlate with tumor responses, and evaluate differences in tumor tissue characteristics in biopsies taken during or post-treatment with pembrolizumab versus baseline. (Study fully enrolled). This study was chosen by the Scientific Program Committee of the American Society of Clinical Oncology (ASCO) for a prestigious poster discussion at the May 2020 ASCO Annual Meeting due to the significance of the study’s results.

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Comprehensive Liposarcoma Study

Completed 10 years of clinical data and 600 biomarkers tested on 41 specimens. Genomic testing (600 genes), IHC, FISH/CISH, and expression analysis were performed on 41 tissue samples and correlated with 10 years of clinical outcomes. One of the largest retrospective studies in liposarcoma to date.

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Retrospective Study on radiation therapy in soft tissue sarcoma treatment

Kneisl, J. S., Ferguson, C., Robinson, M., Crimaldi, A., Ahrens, W., Symanowski, J., . . . Kim, E. S. (2017). The effect of radiation therapy in the treatment of adult soft tissue sarcomas of the extremities: A long-term community-based cancer center experience. Cancer Medicine,6(3), 516-525. doi:10.1002/cam4.972

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We are proud to partner with Levine Cancer Institute and Levine Children’s Hospital and fund these outstanding trials and studies, working together to improve patients’ lives and discover sarcoma cures.

Read more about our research beneficiaries.


Physician researchers at Levine Cancer Institute discuss how the research partnership with our foundation elevates hope, increases awareness, and creates community.

Dr. Edward Kim, former Chair of Solid Tumor Oncology and Investigative Therapeutics, Atrium Health’s Levine Cancer Institute, discusses results of the Institute’s first pilot study in soft tissue sarcomas; its poster discussion honor at ASCO 2020, and its ability to conduct significant investigator-initiated research through its partnership with the Paula Takacs Foundation for Sarcoma Research.

survivor patient


              –Hank Povinelli, Levine Cancer Institute Patient