SARC032 (Sarcoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether combining pembrolizumab with radiation therapy and surgery can prevent the growth and spread of cancer to other parts of the body.

What is the Condition Being Studied?

Soft tissue sarcoma of the arms or legs

Who Can Participate in the Study?

Adults who:
- Have a diagnosis of soft tissue sarcoma of the arms or legs
- Have not had prior chemotherapy, targeted small molecule therapy, or radiation therapy for their current sarcoma
- Have not had radiation therapy (more than 20 Gy) to the site of the current sarcoma.

Age Group

What is Involved?

If you join this study, you will
Be randomly assigned (like the flip of a coin) to one of the two groups:

- Patients in Group 1 will get radiation plus a study drug called pembrolizumab by IV every 3 weeks for 3 cycles before surgery. After surgery, you could get up to 14 more cycles of pembrolizumab (up to one year after the start of treatment)

- Patients in Group 2 will get radiation therapy and surgery alone (this is the standard of care for sarcoma)

Study Details

Full Title
A Phase 2 Randomized Controlled Trial of Neoadjuvant Pembrolizumab with Radiotherapy and Adjuvant Pembrolizumab in Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00081828
NCT: NCT03092323
Phase II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center