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This trial is open to enrollment.

Pembrolizumab and Radiation Therapy to Improve Outcome in High-Risk Sarcoma

Meet our Sarcoma Clinical Trial Team

David Kirsch, MD, PhD

University ProfessorDuke University Medical CenterView Bio

David Kirsch, MD, PhD, is the Barbara Levine University Professor at Duke in the Departments of Radiation Oncology and Pharmacology & Cancer Biology. After graduating from Duke with a BS in Biology, he completed the MD/PhD program at Johns Hopkins School of Medicine, where he performed his thesis research with Dr. Michael Kastan. After an internship in Internal Medicine, Dr. Kirsch trained in radiation oncology at Massachusetts General Hospital. He worked as a post-doc in the laboratory of Dr. Tyler Jacks at M.I.T., where he developed a genetically engineered mouse model of soft tissue sarcoma. In 2007 Dr. Kirsch moved to Duke, where he uses radiation therapy to care for patients with sarcomas at the Duke Cancer Center. Dr. Kirsch is the leader of the Radiation Oncology & Imaging Program in the Duke Cancer Institute and serves as Vice Chair for Basic and Translational Research in the Department of Radiation Oncology. Dr. Kirsch’s laboratory utilizes sophisticated genetically engineered mouse models to study mechanisms of sarcoma and normal tissue response to radiation: http://www.kirschlab.org

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Meet the Team

  • David G. Kirsch, MD, PhD, Duke University Medical Center
  • Karla Ballman, PhD, Weill Cornell Medical College
  • Brian Brigman, MD, PhD, Duke University Medical Center
  • George Demetri, MD, Dana-Farber Cancer Institute
  • William Eward, MD, University Medical Center
  • David Followill, PhD, MD Andereson Cancer Center
  • Yvonne M. Mowery, MD, PhD, Duke University Medical Center
  • Denise Reinke, PhD, Sarcoma Alliance for Research Through Collaboration (SARC)
  • Scott Schuetze, MD, PhD, University of Michigan
  • William Tapp, MD, Memorial Sloan Kettering Cancer Center
  • Matt Van de Rijin, MD, Stanford University
  • Andrew Wagner, MD, PhD, Dana-Farber Cancer Institute
  • Kent Weinhold, PhD, Duke University Medical Center

 

  • Patient Advocate: Corrie Painter, PhD
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About this SU2C Catalyst Clinical Trial

Do you have cancer of the connective tissues (sarcoma) that has not spread (metastasized)? Stand Up To Cancer (SU2C) is supporting a clinical trial being conducted by SARC that may help prevent sarcomas from spreading, and improve the outcomes for patients like you.

Treatment for patients with sarcoma often involves radiation therapy before the tumor is removed with surgery. Studies suggest that when this radiation therapy is combined with a type of immunotherapy drug, called an immune checkpoint inhibitor, it could prevent sarcomas from spreading and improve outcomes for patients.

What is Pembrolizumab?

A humanized antibody used in cancer immunotherapy. It blocks a protective mechanism on cancer cells, and allows the immune system to destroy those cancer cells

Researchers on the SU2C-SARC032 Sarcoma Clinical Trials Team will test whether combining pembrolizumab with preoperative radiation therapy, along with additional pembrolizumab after surgery, can reduce the growth of tumors that may have spread. Researchers think that this combination of therapies may stimulate your own body’s immune response to cancer, helping to prevent a life-threatening spread of the disease.

This research may lead to a new “standard of care” for sarcoma patients, in other words, a new definition of the “best approach” that physicians should use to treat these cancers. It may also help guide researchers to what treatments they should test for other cancers.

This clinical trial is an initiative of the SU2C-SARC032 Sarcoma Clinical Trials Team, which seeks to bring new treatments to patients faster.

We Need You

Why Your Participation Matters

This trial could potentially change the standard treatment for patients with established sarcoma, make it less likely that these cancers will spread, and improve the survival rates for patients with these cancers of the connective tissues. Your participation in this clinical trial will help move science forward. Your involvement is needed to help improve outcomes for cancer patients using a combination of radiation treatment with cutting-edge immunotherapy.

Key Insights for Participants

Eligibility

Patients with confirmed diagnosis of either undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma of the extremity are eligible to enroll. There are additional criteria that must be met to participate, or that may prevent a patient from participating.

Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.

Gender:
Female or Male
Age Range:
12 years and older
Diagnosis:
Patients with large, aggressive sarcomas of the arms and legs that meet specific histological subtypes with no evidence of spread of the tumor to the lungs or other sites

Requirements

Your cancer must not have spread, but have a high risk of spreading (intermediate to high-grade tumor; approximately 50% risk for distant disease at 2 years). A medical image (such as a CT scan) will be

used to ensure that your cancer has not visibly spread.

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Your primary tumor must be greater than 5cm in any direction and must be “resectable,” which means that a doctor believes that she or he could probably remove all visible parts of the tumor through surgery.

You must NOT have undergone prior chemotherapy, targeted small molecule therapy, or radiation therapy for your current diagnosis of sarcoma.

You are NOT eligible to participate in the study if you have already received radiation therapy (of more than 20 Gy) to the site where you currently have a sarcoma tumor.

Within 10 days of the time you begin the trial, you will still need to have good functioning of your major organs such as kidneys, liver, heart, lungs. The primary trial investigator will make that decision.

Before beginning the trial you must be well enough to care for yourself and perform daily activities like light housework, light exercise or office work. This is determined by scoring 0 or 1 on the ECOG Performance Status Test.

You are NOT eligible to participate in this study if you have a known, different type of malignant cancer that got worse or required treatment within the last two years.

You are also NOT eligible to participate if you are part of another study or have been part of another study within 4 weeks of enrolling in this study. Note: You MAY participate if you have had basal cell carcinoma of the skin, squamous cell carcinoma of the skin, other “in-situ” (in place, that hasn’t spread) carcinoma, or low-risk prostate cancer.

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You may NOT participate in this study if you have another significant illness at the same time that you are taking part in the trial. This is for your own safety as well as to make sure that the results of the trial are accurate. The trial investigator will make the decision.

If you are physically able to become pregnant, you must have a negative pregnancy test (a blood test ordered by your doctor) within the 72-hour period prior to beginning this study’s treatment.

You are NOT eligible to participate in this clinical trial if you are pregnant, expecting to conceive a child either during this study or within four months following your last treatment in this study, or are breast feeding.

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If you are fertile (both men and women) you must agree to use an effective birth control method from the time of enrollment until 120 days after receiving the last treatment dose in this study.

Participate

You play a vital role.

Here are the locations where you can participate in this clinical trial. If interested, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and can answer any questions.

The patient coordinator will start by reviewing your medical history with you to see whether you meet all the criteria to participate. Then, the coordinator will guide you through review and signature on detailed “informed consent” documents that are required when you enroll in a clinical trial.

Raleigh/Durham - North Carolina

Duke Cancer Institute
Colleen Piechocki
P: 919-681-41768
Contact

Resources

Support for this study comes from Merck.
Learn more about Merck +
Here are some links to organizations that provide more information about sarcoma, and may provide information on patient support, treatment options, and current clinical trials.
Sarcoma Foundation of America +Sarcoma Alliance +
For additional resources, please visit StandUpToCancer.org +

Find out if there's a trial for you. Reach out today.

Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.

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