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Sarcoma Immunotherapy Clinical Trial Available in Spain

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

24 September, 2023

Ensayo clínico de inmunoterapia en sarcomas disponible en España

To participate in this clinical trial, please call +34 607 939 266 or write to info@sofpromed.com

Patients who may benefit from this clinical trial are those diagnosed with dedifferentiated chondrosarcoma, extraskeletal myxoid chondrosarcoma, alveolar soft part sarcoma, clear cell sarcoma, undifferentiated pleomorphic sarcoma, and osteosarcoma.

In this article you will learn about:

Sarcomas are malignant tumors arising in the bones and soft tissues of the body. 

It is a rare cancer that accounts for only 1% of all tumors diagnosed in adults.

Sarcomas are actually a very heterogeneous group of more than 60 different tumor subtypes, which significantly complicates the development of effective new treatments.

As these are rare and aggressive tumors, with an estimated incidence of about 7 cases per 100,000 people, there are currently no effective treatments for sarcoma patients who relapse from their disease and experience metastases.  

Generally, soft tissue sarcomas have a 5-year survival rate of approximately 65%.

Nevertheless, when soft tissue sarcomas spread to other parts of the body (metastasis) the 5-year survival rate is 18%. 

Unfortunately, there are no treatments available for patients with metastatic sarcomas that can totally cure them. 

There are chemotherapies and new drugs that are improving progression-free survival, but the need is still great for patients with advanced sarcomas.

New ImmunoSarc2 Clinical Trial in Spain

Dr. Javier Martín-Broto, medical oncologist at the Fundación Jiménez Díaz University Hospital in Madrid, and international expert in sarcomas, has launched the ImmunoSarc2 clinical trial in collaboration with the Spanish Sarcoma Research Group (GEIS).

ImmunoSarc2 is a highly innovative clinical trial focused on immunotherapy-based treatments for certain types of soft tissue and bone sarcomas. 

Chondrosarcomas, Alveolar Soft Part Sarcoma, and Clear Cell Sarcoma

The combination of the drugs sunitinib (antiangiogenic agent) and the immunotherapy nivolumab (PD-1 inhibitor) is being tested in the following advanced or metastatic sarcomas:

  • Dedifferentiated chondrosarcoma
  • Extraskeletal myxoid chondrosarcoma
  • Alveolar soft-part sarcoma
  • Clear cell sarcoma

Undifferentiated Pleomorphic Sarcoma

For patients with undifferentiated pleomorphic sarcoma (in first line of advanced disease), a cohort is open with a new combination scheme that includes the chemotherapies epirubicin and ifosfamide, and the immunotherapy nivolumab.

Osteosarcoma

Finally, a new treatment is offered for adult and pediatric patients (12 years and older) with osteosarcomas, specifically for high-grade osteosarcomas with metastases, the primary tumor being operable, who have not received previous chemotherapies.

Encouraging Results

Dr. Javier Martín-Broto states:

“It’s a great privilege to be able to offer these anti-PD1 combinations to patients diagnosed with some sarcoma subtypes. We are very happy with some of the results we are getting. There are patients with advanced sarcoma who, after years of treatment, are still in almost complete response, for example in dedifferentiated chondrosarcoma or in alveolar soft part sarcoma. The result obtained in leiomyosarcoma with chemotherapy and nivolumab practically doubles what was achieved with the best combination chemotherapy available for first line in advanced leiomyosarcomas. These results were presented at the American Society of Clinical Oncology (ASCO) meeting in 2023. Similarly, we are seeing that chemotherapy and nivolumab are also very active in first-line undifferentiated pleomorphic sarcoma. The information generated by this research will be relevant to understand in which subtypes of sarcoma and with which strategy we achieve the best results.”

Access to the ImmunoSarc2 Clinical Trial in Spain

The ImmunoSarc2 clinical trial is open in several Spanish hospitals, including Madrid, Barcelona, Seville, Valencia, Zaragoza, Canary Islands and Murcia.

Patients interested in learning more about this clinical trial and exploring their possibilities of participation can contact the study coordinating team (phone +34 607 939 266, info@sofpromed.com)

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com