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ACTIVE NOT RECRUITING
NCT03092323
PHASE2

A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity

Sponsor: Sarcoma Alliance for Research through Collaboration

View on ClinicalTrials.gov

Summary

This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

Official title: SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2017-07-19

Completion Date

2028-09-01

Last Updated

2023-11-18

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.

Locations (20)

University of California Los Angeles

Los Angeles, California, United States

Mayo Clinic- Florida

Jacksonville, Florida, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania- Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh (UPMC Hillman Cancer Center)

Pittsburgh, Pennsylvania, United States

Chris O'Brien Hospital

Camperdown, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

McGill University Health Centre

Montreal, Quebec, Canada

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy