Pembrolizumab + Radiation Therapy for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial compares the effect of adding doxorubicin and ifosfamide (AIM chemotherapy) before (neoadjuvant) receiving standard treatment with pembrolizumab, radiation therapy and surgery to standard of care treatment alone in treating patients with high-risk soft-tissue sarcomas, such as undifferentiated pleomorphic sarcoma (UPS) or liposarcoma (LPS), that originate in the arms, legs (extremity) or torso (trunk wall) and can be removed by surgery (resectable). Doxorubicin comes from the bacterium Streptomyces peucetius. It damages deoxyribonucleic acid (DNA) and may kill tumor cells. It is a type of anthracycline antitumor antibiotic. Ifosfamide attaches to DNA in cells and may kill tumor cells. It is a type of alkylating agent and a type of antimetabolite. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy (IMRT)is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. Giving neoadjuvant doxorubicin and ifosfamide with standard of care pembrolizumab, radiation therapy and surgery may be safe, tolerable, and/or more effective than standard of care therapy alone in treating patients with high-risk resectable soft tissue sarcoma of the arms, legs, or torso.
Who Is on the Research Team?
David A Liebner
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with high-risk soft tissue sarcoma (undifferentiated pleomorphic sarcoma or liposarcoma) in the arms, legs, or torso that can be removed by surgery. Participants should be healthy enough for chemotherapy and surgery.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Doxorubicin
- Ifosfamide
- Intensity-Modulated Radiation Therapy
- Pembrolizumab
Trial Overview
The study compares standard treatment (pembrolizumab immunotherapy, radiation therapy, and surgery) to the same treatment plus chemotherapy drugs doxorubicin and ifosfamide given before other treatments. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
See Detailed Description
NEOADJUVANT: Patients receive standard of care pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 8, patients undergo radiation therapy, patients undergo IMRT QD on Monday-Friday (5 days per week) for up to 25 fractions (5 weeks) per standard of care. Starting 4-6 weeks after completing radiation therapy, patients undergo oncologic resection per standard of care. POST-SURGERY: Starting 1-4 weeks after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle per standard of care. Cycles repeat every 21 days for up to a total of 17 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo TTE or MUGA at screening, and blood sample collection, CT and MRI throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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