A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03092323|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma of the Extremity||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 19, 2017|
|Estimated Primary Completion Date :||July 1, 2024|
|Estimated Study Completion Date :||July 30, 2025|
Neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab.
Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.
Other Name: KEYTRUDA®
No Intervention: Standard of Care
Neoadjuvant radiotherapy followed by surgical resection.
- Disease free survival [ Time Frame: 2 Years ]Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence.
- Loco-regional disease-free survival [ Time Frame: 5 years ]The length of time after treatment ends without any locoregional recurrence of sarcoma.
- Distant disease free survival [ Time Frame: 5 years ]The length of time after treatment ends that the patient survives without any signs or symptoms of sarcoma
- Overall survival [ Time Frame: 5 years ]The length of time from the start of treatment that patients diagnosed with sarcoma are still alive.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]Test the safety of neoadjuvant pembrolizumab administered with conventionally fractionated radiotherapy targeting soft tissue sarcoma of the extremity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092323
|Contact: SARC Trials||734-930-7600||SARC@sarctrials.org|
|Principal Investigator:||David Kirsch, MD, PhD||Duke University|