A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
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|ClinicalTrials.gov Identifier: NCT03092323|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 15, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma of the Extremity||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 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 :||September 1, 2025|
|Estimated Study Completion Date :||September 1, 2028|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 12 years
- Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than 5 cm in any direction as assessed by imaging
- Patients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.
- ECOG Performance Status of 0 or 1
- Resectable primary tumor with no evidence of metastatic disease by imaging.
- Adequate organ function within 10 days of Day 1
- Written, voluntary informed consent
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 120 days after last pembrolizumab administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy for current diagnosis of sarcoma
- Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
- Concurrent, clinically significant, active malignancies within two years of study enrollment.
- Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
- Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- Major surgery within four weeks prior to Day 1 of study or who have not recovered adequately from prior surgery.
- Currently receiving a study therapy or if they had an investigational agent within 4 weeks at the time of enrollment.
- Women who are pregnant or nursing/breastfeeding, or expecting to conceive or men who are expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of pembrolizumab.
- Inability to comply with protocol required procedures
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy by oral or IV routes within 7 days prior to the first dose of trial treatment
- Known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients
- Metastatic disease or regional lymph node involvement. Chest CT will be mandatory prior to enrollment to evaluate for the presence of metastatic disease. Pulmonary nodule(s) < 5 mm without a histological diagnosis may not be the basis for study exclusion given the lack of specificity of chest CT. If pulmonary nodule(s) measuring 6 - 10 mm are noted on chest CT but appear stable relative to prior chest imaging of at least 6 months duration or if 18FDG-PET scan indicates that the nodule(s) are unlikely to be metastatic disease, then this is permitted. Pulmonary nodules >10 mm should be considered metastatic unless proven otherwise by biopsy/resection or stable appearance for at least 6 months on imaging.
- Unresectable disease or medically inoperable
- Planned to receive neoadjuvant or adjuvant chemotherapy for current diagnosis of localized soft tissue sarcoma
- Active autoimmune disease that has required systemic treatment in the past two years (i.e. with use of disease modifying agents, systemic corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
- Active infection requiring systemic therapy
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Known active Hepatitis B (e.g., HBsAg reactive, confirmed by detectable viral load) or Hepatitis C (e.g., HCV RNA [qualitative] detected)
- Received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Diagnosis of scleroderma.
- Diagnosis of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis).
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|
|Responsible Party:||Sarcoma Alliance for Research through Collaboration|
|Other Study ID Numbers:||
|First Posted:||March 27, 2017 Key Record Dates|
|Last Update Posted:||May 15, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action