Pembrolizumab + Radiation Therapy for Soft Tissue Sarcoma

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ohio State University Comprehensive Cancer Center
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

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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

I am eligible for radiation before surgery to help control my soft tissue sarcoma.
Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) or eGFR ≥ 60 ml/min/m^2 for patients with serum creatinine > 1.5 x ULN
Hemoglobin ≥ 9.0 g/dL without transfusion within 7 days of enrollment
See 17 more

Exclusion Criteria

I have been treated with doxorubicin or similar chemotherapy drugs before.
I do not have serious heart problems or recent heart attacks.
Any medically significant comorbidity that would preclude safe participation in the study in investigator's opinion
See 13 more

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

Group I: Arm A (AIM, pembrolizumab, IMRT, surgery)Experimental Treatment11 Interventions
Group II: Arm B (pembrolizumab, IMRT, surgery)Active Control9 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+